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(1) Phenylpropanolamine for weight reduction. Med Lett Drugs Ther 1984 June 8;26(663):55-6.

(2) Abell CA, Farquhar DL, Galloway SM, Steven F, Philip AE, Munro JF. Placebo controlled double-blind trial of fluvoxamine maleate in the obese. J Psychosom Res 1986;30(2):143-6.

Abstract: Obesity and depression are common disorders which may co-exist. The management of the combination is complicated because some antidepressants cause weight gain fenfluramine, an effective antiobesity agent, may cause depression. Fluvoxamine is an antidepressant which, like fenfluramine, inhibits serotonin re-uptake within the brain. Forty obese female subjects with refractory obesity participated in a double-blind placebo controlled trial. During the twelve week study, those subjects receiving fluvoxamine achieved a mean weight loss greater than, but not significantly different from, that of the placebo group. The result suggests that fluvoxamine may be particularly useful in the management of obese patients requiring treatment with an antidepressant

(3) Abramson R, Garg M, Cioffari A, Rotman PA. An evaluation of behavioral techniques reinforced with an anorectic drug in a double-blind weight loss study. J Clin Psychiatry 1980 July;41(7):234-7.

Abstract: Sixty obese outpatients participated in a double-blind comparison of diethylpropion hydrochloride and placebo in conjunction with a behavior modification program for weight reduction. Assessments of efficacy and program acceptance included total weight loss, percent of initial (baseline) weight loss, percent excess weight lost, effectiveness of overall program, and helpfulness of medication. Diethylpropion was significantly better than placebo in all five assessments. An added behavioral technique, a substantial refundable deposit of money, reduced the attrition rate of all study entrants from 50% to 10%; thus patient compliance was greatly enhanced

(4) Akobeng AK, Miller V, Stanton J, Elbadri AM, Thomas AG. Double-blind randomized controlled trial of glutamine-enriched polymeric diet in the treatment of active Crohn's disease. J Pediatr Gastroenterol Nutr 2000 January;30(1):78-84.

(5) Alger S, Larson K, Boyce VL et al. Effect of phenylpropanolamine on energy expenditure and weight loss in overweight women. Am J Clin Nutr 1993 February;57(2):120-6.

Abstract: The effect of phenylpropanolamine (PPA), a noncatecholamine sympathomimetic weight-loss agent, on energy expenditure (EE) and substrate oxidation was measured in a respiratory chamber in 24 overweight women after 4 d of treatment (PPA or placebo) during weight maintenance and after 7 wk of treatment on a hypoenergetic diet (70% of measured baseline 24-h EE). Twelve women (37 +/- 2 y, 74 +/- 6 kg, 33 +/- 1% body fat) were randomly assigned to the PPA group [75 mg osmotic release oral system (OROS)-PPA/d] and 12 (mean +/- SEM: 38 +/- 2 y, 79 +/- 1 kg, 37 +/- 1% body fat) to the placebo group. Baseline measurements of 24-h EE (7849 +/- 226 vs 7834 +/- 142 kJ/d), basal metabolic rate (BMR) and 24-h respiratory quotient (RQ) were comparable between PPA and placebo groups. After 4 d of treatment, there was no significant effect of PPA on 24-h EE, BMR, and 24-h RQ compared with placebo. Over the 7-wk diet period, however, the PPA group (n = 8) had greater weight loss than the placebo group (n = 10): -5.0 +/- 0.5 vs - 3.0 +/- 0.4 kg (P < 0.05). The changes in 24-h EE and 24-h RQ over the 7 wk were not different between the groups. We conclude that weight loss is enhanced by OROS-PPA, but this change was not explained by changes in 24-h EE or 24-h RQ. The small number of subjects may have hindered detection of subtle differences in energy metabolism

(6) Alger S, Larson K, Boyce VL et al. Effect of phenylpropanolamine on energy expenditure and weight loss in overweight women. Am J Clin Nutr 1993 February;57(2):120-6.

(7) Altschuler S, Conte A, Sebok M, Marlin RL, Winick C. Three controlled trials of weight loss with phenylpropanolamine. Int J Obes 1982;6(6):549-56.

Abstract: A multisite double-blind study was designed to determine the effectiveness of a phenylpropanolamine-caffeine combination in achieving weight loss. Two-hundred and one obese adult patients were divided into three separate groups in which phenylpropanolamine/caffeine was compared with either placebo (6 weeks), mazindol (6 weeks), or diethylpropion (8 weeks). In these clinical trials, phenylpropanolamine/caffeine proved to be as effective as mazindol and diethylpropion and significantly more effective than placebo in achieving weight loss. Overall, phenylpropanolamine/caffeine had fewer side effects than mazindol and diethylpropion. Its use as an effective anorectic agent in the treatment of obesity is reviewed

(8) Andersen PH, Richelsen B, Bak J et al. Influence of short-term dexfenfluramine therapy on glucose and lipid metabolism in obese non-diabetic patients. Acta Endocrinol (Copenh) 1993 March;128(3):251-8.

(9) Andersen T, Fogh J. Weight loss and delayed gastric emptying following a South American herbal preparation in overweight patients. J Hum Nutr Diet 2001 June;14(3):243-50.

(10) Astrup A, Buemann B, Christensen NJ et al. The effect of ephedrine/caffeine mixture on energy expenditure and body composition in obese women. Metabolism 1992 July;41(7):686-8.

(11) Astrup A, Toubro S, Cannon S, Hein P, Madsen J. Thermogenic synergism between ephedrine and caffeine in healthy volunteers: a double-blind, placebo-controlled study. Metabolism 1991 March;40(3):323-9.

(12) Astrup A, Buemann B, Christensen NJ et al. The effect of ephedrine/caffeine mixture on energy expenditure and body composition in obese women. Metabolism 1992 July;41(7):686-8.

(13) Astrup A, Breum L, Toubro S, Hein P, Quaade F. The effect and safety of an ephedrine/caffeine compound compared to ephedrine, caffeine and placebo in obese subjects on an energy restricted diet. A double blind trial. Int J Obes Relat Metab Disord 1992 April;16(4):269-77.

(14) Atkinson RL, Berke LK, Drake CR, Bibbs ML, Williams FL, Kaiser DL. Effects of long-term therapy with naltrexone on body weight in obesity. Clin Pharmacol Ther 1985 October;38(4):419-22.

Abstract: The endogenous opiate system is thought to be associated with the regulation of food intake and body weight. Opiate antagonists decrease food intake in animals, but there are no controlled studies in obese man to evaluate body weight response to naltrexone. Sixty obese people were randomized into three groups and given 0, 50, or 100 mg of the opiate antagonist naltrexone for 8 weeks in an outpatient, double-blind study. Weight loss was not significant in either the 50 or 100 mg groups as compared with placebo. However, when broken down by sex, women had a significant (P less than 0.05) weight loss of 1.7 kg, while men did not lose weight. Side effects were modest, but six subjects had one or more abnormal liver function test results; in one subject these abnormalities appeared to be clinically significant. The effects of naltrexone on weight loss were less than expected in light of prior animal studies, but further studies with a wider dose range of naltrexone may be indicated

(15) Atkinson RL, Greenway FL, Bray GA et al. Treatment of obesity: comparison of physician and nonphysician therapists using placebo and anorectic drugs in a double-blind trial. Int J Obes 1977;1(2):113-20.

Abstract: In a randomized double-blind trial, 60 obese patients were assigned in groups of 12 to five therapists. The patients for each therapist were then randomly assigned in groups of four to placebo or one of two preparations of mazindol. Ninety-three percent of the patients completed the nine weeks of treatment. Weight loss averaged 1.1 lb per week and there was no advantage to pharmacological agents over placebo. However, there were significant differences between therapists. Weight loss by the patients assigned to physicians was no better than for those assigned to nonphysician personnel, but there were significant differences between individual nonphysician personnel. These findings support the concept that nonphysician personnel may be effective in treating many obese patients. In addition, we could not find a significant effect of either form of mazindol when compared to placebo

(16) Baird IM, Howard AN. A double-blind trial of mazindol using a very low calorie formula diet. Int J Obes 1977;1(3):271-8.

Abstract: Thirty-eight obese patients, resistant to conventional diet therapy, agreed to consume a 1.09 MJ (260 kcal)/day semi-synthetic diet consisting of 25 g egg albumin, 40 g oligosaccharides, vitamins and minerals, and were seen weekly as outpatients for eight weeks. At the beginning, the semi-synthetic diet was given with either the anorectic drug, mazindol (2 mg/day) or a placebo for four weeks and then changed over for the remaining four weeks; the study being conducted on a double-blind basis. The final treatment was a 4.2 MJ (1000 KCAL) conventional diet for a further four weeks without drug or placebo. Twenty-five patients completed the first eight weeks and 21 patients the final four weeks of the trial. The total mean weight losses were as follows: week 4, 9.3 kg; week 8, 13.7 kg; week 12, 12.2 kg. There was no significant difference in weight loss between mazindol treatment and placebo but the former group reported feeling less hungry. The chief side-effects observed were dizziness, nausea, dry mouth, insomnia and depression which were more frequent with mazindol. Six patients had to stop mazindol because of side-effects, but were able to continue the diet alone. It is concluded that a semi-synthetic diet containing 1.09 MJ (260 kcal) daily can be successfully employed in the treatment of obese outpatients, and is a practical therapeutic alternative to admission to hospital. There is no clinical advantage to be gained by the additional use of the anorectic drug, mazindol

(17) Benjamin SB, Maher KA, Cattau EL, Jr. et al. Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for exogenous obesity. Gastroenterology 1988 September;95(3):581-8.

Abstract: Since its approval by the Food and Drug Administration in September 1985, the Garren-Edwards gastric bubble has been extensively used as an adjunct to diet and behavioral modification in the treatment of exogenous obesity. In an attempt to evaluate the efficacy of the Garren-Edwards gastric bubble, a double-blind crossover study was undertaken. Ninety patients were randomized into three groups: bubble-sham, sham-bubble, and bubble-bubble in two successive 12-wk periods. Sixty-one patients completed the entire 24-wk study. All groups participated in ongoing diet and behavioral modification therapy in a free-standing obesity program, the members of which were blinded to randomization arms. All patient groups lost weight during this study. The mean cumulative weight loss in pounds at 12 wk was as follows: bubble-sham = 19, sham-bubble = 12, and bubble-bubble = 8; and at 24 wk: bubble-sham = 23, sham-bubble = 16, and bubble-bubble = 18. The mean cumulative change in body mass index (kg/m2) at 12 wk was as follows: bubble-sham = -3.1, sham-bubble = -2.3, and bubble-bubble = -2.9; and at 24 wk: bubble-sham = -3.1, sham-bubble = -3.0, and bubble-bubble = -3.3. Although weight loss occurred more consistently in patients with a Garren-Edwards gastric bubble, there were no significant differences between any of the three groups at 12 or 24 wk with respect to weight loss or change in body mass index. The major part of the weight loss noted during this study occurred during the first 12-wk period, irrespective of therapy (bubble or sham). Side effects observed during this study included gastric erosions (26%), gastric ulcers (14%), small bowel obstruction (2%), Mallory-Weiss tears (11%), and esophageal laceration (1%). We conclude that, in this study, the use of a Garren-Edwards gastric bubble did not result in significantly more weight loss than diet and behavioral modification alone in the management of exogenous obesity, and it may result in significant morbidity

(18) Berkowitz RI, Wadden TA, Tershakovec AM, Cronquist JL. Behavior therapy and sibutramine for the treatment of adolescent obesity: a randomized controlled trial. JAMA 2003 April 9;289(14):1805-12.

(19) Bigelow GE, Griffiths RR, Liebson I, Kaliszak JE. Double-blind evaluation of reinforcing and anorectic actions of weight control medications. Interaction of pharmacological and behavioral treatments. Arch Gen Psychiatry 1980 October;37(10):1118-23.

Abstract: Within a behavioral self-management treatment program for overweight, 59 patients were randomly assigned to receive as an adjunct either dextroamphetamine sulfate, fenfluramine hydrochloride, or placebo in a double-blind procedure. Patients self-regulated their drug intake during a four-week medication period. Two types of behavioral-pharmacological interaction were observed: (1) drug assignment influenced participation in the behavioral treatment; and (2) drug assignment influenced the extent of medication self-administration. The dextroamphetamine group was superior in terms of behavioral treatment participation, extent of eating and exercise habit change, and weight loss. Self-administration of dextroamphetamine was most well-maintained--showing it to be a reinforcer--and self-administration of fenfluramine was suppressed below placebo levels. No patient taking either drug showed excessive drug intake, and all were, in fact, conservative in drug use. These data concerning relative reinforcing efficacy within a therapeutic medication setting are discussed in relation to data from animal models used to assess relative abuse liability of these drugs

(20) Birketvedt GS, Aaseth J, Florholmen JR, Ryttig K. Long-term effect of fibre supplement and reduced energy intake on body weight and blood lipids in overweight subjects. Acta Medica (Hradec Kralove) 2000;43(4):129-32.

(21) Birketvedt GS, Thom E, Bernersen B, Florholmen J. Combination of diet, exercise and intermittent treatment of cimetidine on body weight and maintenance of weight loss. A 42 months follow-up study. Med Sci Monit 2000 July;6(4):699-703.

(22) Bitsch M, Skrumsager BK. Femoxetine in the treatment of obese patients in general practice. A randomized group comparative study with placebo. Int J Obes 1987;11(2):183-90.

Abstract: A study was carried out in general practice to compare the effectiveness of femoxetine, a selective serotonin reuptake inhibitor, with the effect of placebo in helper patients more than 20 per cent above their ideal weight to lose weight. Patients were allocated at random to receive either 600 mg femoxetine (36 patients) or placebo (37 patients) daily over a period of 16 weeks. They were also asked to restrict their calorie intake to 1200-1600 kcal. (5.0-6.7 MJ)/day. The results showed that there was no statistically significant greater weight loss in patients treated with femoxetine (median = 8.3 kg) than with placebo (median = 6.2 kg) after 16 weeks. In subgroups of patients with obesity problems for more than 20 years and of patients previously in anorectic treatment, femoxetine tended towards causing a larger weight loss. Side-effects were generally minor in nature, and the incidence and nature of them were almost comparable in the two groups except for gastro-intestinal symptoms, which were reported more often in the femoxetine group. As femoxetine in several randomized group comparative studies in depressive illness has been shown to have an antidepressant efficacy which is comparable with the efficacy amitriptyline and imipramine, femoxetine may be particularly useful in the management of obese patients requiring antidepressant treatment

(23) Bondi M, Menozzi R, Bertolini M, Venneri MG, Del Rio G. Metabolic effects of fluoxetine in obese menopausal women. J Endocrinol Invest 2000 May;23(5):280-6.

(24) Boozer CN, Nasser JA, Heymsfield SB, Wang V, Chen G, Solomon JL. An herbal supplement containing Ma Huang-Guarana for weight loss: a randomized, double-blind trial. Int J Obes Relat Metab Disord 2001 March;25(3):316-24.

(25) Borovicka MC, Fuller MA, Konicki PE, White JC, Steele VM, Jaskiw GE. Phenylpropanolamine appears not to promote weight loss in patients with schizophrenia who have gained weight during clozapine treatment. J Clin Psychiatry 2002 April;63(4):345-8.

Abstract: BACKGROUND: Weight gain is a common side effect of clozapine treatment and may expose patients to obesity-associated health risks. We proposed that concomitant treatment with an appetite suppressant such as phenylpropanolamine (PPA) would lead to a decrease in appetite and therefore loss of weight. METHOD: This was a 12-week, double-blind, randomized, placebo-controlled trial of PPA, 75 mg/day, in outpatients with treatment-refractory schizophrenia (DSM-IV) who were stable on clozapine treatment for at least 4 months and had gained > 10% of their baseline body weight since starting clozapine. Patients were evaluated for adverse effects and weighed weekly. A Positive and Negative Syndrome Scale (PANSS) assessment, a short dietary quiz, and blood indices were completed monthly. RESULTS: Sixteen patients were equally randomly assigned to receive PPA or placebo. The groups did not differ in mean age, baseline weight, dose of clozapine, baseline PANSS scores, or the percent of weight gained since the start of clozapine. There was no significant effect of treatment on weight (t = 0.219, df = 10, p = .831). There was no significant change in either the total PANSS scores (t = -0.755, df = 10, p = .468), the positive or negative symptom cluster scores, or any of the remaining variables. CONCLUSION: Phenylpropanolamine 75 mg/day was well tolerated but was not effective in reversing established weight gain associated with clozapine treatment in stable outpatients with schizophrenia

(26) Bosch B, Venter I, Stewart RI, Bertram SR. Human chorionic gonadotrophin and weight loss. A double-blind, placebo-controlled trial. S Afr Med J 1990 February 17;77(4):185-9.

Abstract: Low-dose human chorionic gonadotrophin (HCG) combined with a severe diet remains a popular treatment for obesity, despite equivocal evidence of its effectiveness. In a double-blind, placebo-controlled study, the effects of HCG on weight loss were compared with placebo injections. Forty obese women (body mass index greater than 30 kg/m2) were placed on the same diet supplying 5,000 kJ per day and received daily intramuscular injections of saline or HCG, 6 days a week for 6 weeks. A psychological profile, hunger level, body circumferences, a fasting blood sample and food records were obtained at the start and end of the study, while body weight was measured weekly. Subjects receiving HCG injections showed no advantages over those on placebo in respect of any of the variables recorded. Furthermore, weight loss on our diet was similar to that on severely restricted intake. We conclude that there is no rationale for the use of HCG injections in the treatment of obesity

(27) Bratusch-Marrain P, Dudczak R, Waldhausl W. [Weight reduction in obese diabetics: a double-blind study of diethylpropionate (author's transl)]. Wien Klin Wochenschr 1979 June 22;91(13):455-8.

Abstract: In a double-blind study 40 overweight maturity-onset diabetics on a weight-reducing diet were randomly assigned to treatment with either the appetite-suppressant diethylpropion hydrochloride (Tenuate), or placebo. After treatment for 8 weeks the mean weight loss achieved by each group was 4.9 and 3.3%, respectively. This approximately equal weight loss was too slight to exert any significant effect on glucose tolerance. Thus, an additional effect of this anorexiant in comparison with diet restriction alone, as described in obese non-diabetic subjects, is not evident in the case of obese diabetic patients

(28) Bray GA, Ryan DH, Gordon D, Heidingsfelder S, Cerise F, Wilson K. A double-blind randomized placebo-controlled trial of sibutramine. Obes Res 1996 May;4(3):263-70.

(29) Breum L, Pedersen JK, Ahlstrom F, Frimodt-Moller J. Comparison of an ephedrine/caffeine combination and dexfenfluramine in the treatment of obesity. A double-blind multi-centre trial in general practice. Int J Obes Relat Metab Disord 1994 February;18(2):99-103.

(30) Broom I, Wilding J, Stott P, Myers N. Randomised trial of the effect of orlistat on body weight and cardiovascular disease risk profile in obese patients: UK Multimorbidity Study. Int J Clin Pract 2002 September;56(7):494-9.

(31) Bross R, Hoffer LJ. Fluoxetine increases resting energy expenditure and basal body temperature in humans. Am J Clin Nutr 1995 May;61(5):1020-5.

(32) Brun LD, Bielmann P, Gagne C, Moorjani S, Nadeau A, Lupien PJ. Effects of fenfluramine in hypertriglyceridemic obese subjects. Int J Obes 1988;12(5):423-31.

Abstract: Forty-four hyperlipidemic obese subjects, selected because of their refractoriness towards diet-therapy, participated voluntarily in a 12-week double-blind study comparing the effects of a long-acting fenfluramine (Ponderal Pacaps) to those of a placebo. In spite of no dietetic intervention, a significant 3-kg weight loss (P less than 0.001) was observed in the fenfluramine-treated group, accompanied by a significant improvement of most atherogenic parameters of plasma lipoproteins. Fenfluramine-induced weight loss produced decrease in total cholesterol (P less than 0.05), total triglycerides (P less than 0.05), LDL cholesterol (P less than 0.05), total apoprotein B (P less than 0.005) and LDL apoprotein B (P less than 0.001). An apoprotein B LDL depletion seemed to occur, as suggested by the reduction of LDL cholesterol/apoprotein B ratio (P less than 0.001). Total plasma apoprotein A did not change but the total apoprotein B/total apoprotein A ratio decreased significantly (P less than 0.005). Moreover, fenfluramine increased both HDL phospholipid (P less than 0.005) and HDL cholesterol (P less than 0.05) resulting in a fall of the atherogenic LDL-cholesterol/HDL cholesterol ratio (P less than 0.001) as well as an elevation of the anti-atherogenic HDL cholesterol/LDL + VLDL cholesterol ratio (P less than 0.001). The placebo group demonstrated some improvement in lipid blood parameters without weight loss, indicating a possible qualitative amelioration of nutritional habits. Thus, fenfluramine reduces the risk for cardiovascular disease in hyperlipidemic obese individuals not responding to behavioral intervention

(33) Buemann B, Marckmann P, Christensen NJ, Astrup A. The effect of ephedrine plus caffeine on plasma lipids and lipoproteins during a 4.2 MJ/day diet. Int J Obes Relat Metab Disord 1994 May;18(5):329-32.

(34) Burge JC, Goon A, Choban PS, Flancbaum L. Efficacy of hypocaloric total parenteral nutrition in hospitalized obese patients: a prospective, double-blind randomized trial. JPEN J Parenter Enteral Nutr 1994 May;18(3):203-7.

(35) Cairella M, Pisculli M, Petraroli AR, Riganelli S, Saracino A, Siani V. [Clinical observations on the treatment of obese patients with dexfenfluramine]. Clin Ter 1990 June 15;133(5):289-97.

Abstract: In a 12-months double-blind study 42 obese patients (5 males, 37 females) were treated either with d-fenfluramine (30 mg daily) or with placebo plus low-calorie diet (1500-1200 kcal daily). Evaluation of treatment efficacy was based on evolution of the initial cohort, weight loss, number of subjects completing treatment, tolerability and events leading to dropout. Patients receiving d-fenfluramine had statistically significant greater weight loss than the placebo group; 30 mg daily proved to be an effective and well tolerated dose of d-fenfluramine with the best long-term activity/acceptability ratio

(36) Carney DE, Tweddell ED. Double blind evaluation of long acting diethylpropion hydrochloride in obese patients from a general practice. Med J Aust 1975 January 4;1(1):13-5.

Abstract: Obese patients encountered in general practice were studied in order to determine whether a long-acting form of diethylpropion hydrochloride (Tenuate Dospan) was more effective than placebo for weight loss. One hundred and two patients completed this double blind, 16-week crossover study. During the first eight weeks, the patients treated with diethylpropion hydrochloride lost significantly (P smaller than 0.001) more weight than the patients treated with placebo (an average of 11-1 lb or 6-4% of their initial weight as compared with 6-2 lb or 3-6% of their initial weight). When the group taking diethylpropion hydrochloride crossed over to placebo for a second eight weeks, they lost an average of 1-5 lb (0-9% of their weight at the start of the second period), while the group who crossed from placebo over to diethylpropion hydrochloride lost an average of 6-7 lb (3-8%). The advantages of diethylpropion hydrochloride over placebo are statistically significant

(37) Carvajal A, Garcia dP, Martin dD, I, Rueda de Castro AM, Velasco A. Efficacy of fenfluramine and dexfenfluramine in the treatment of obesity: a meta-analysis. Methods Find Exp Clin Pharmacol 2000 June;22(5):285-90.

(38) Ceci F, Cangiano C, Cairella M et al. The effects of oral 5-hydroxytryptophan administration on feeding behavior in obese adult female subjects. J Neural Transm 1989;76(2):109-17.

Abstract: Nineteen obese female subjects with body mass index ranging between 30 and 40 were included in a double-blind crossover study aimed at evaluating the effects of oral 5-hydroxytryptophan administration on feeding behavior, mood state and weight loss. Either 5-hydroxytryptophan (8 mg/kg/day) or placebo was administered for five weeks during which patients were not prescribed any dietary restrictions. Feeding behavior was investigated by means of a questionnaire designed to establish the onset of anorexia and related symptoms. Food intake was evaluated using a three-day diet diary. BDI, SI, STAI-T, and STAI-S were used to assess mood state. The administration of 5-hydroxytryptophan resulted in no changes in mood state but promoted typical anorexia-related symptoms, decreased food intake and weight loss during the period of observation

(39) Chabrol H, Peresson G, Callahan S. About orlistat. Eat Weight Disord 2001 September;6(3):171-3.

(40) Chow CC, Ko GT, Tsang LW, Yeung VT, Chan JC, Cockram CS. Dexfenfluramine in obese Chinese NIDDM patients. A placebo-controlled investigation of the effects on body weight, glycemic control, and cardiovascular risk factors. Diabetes Care 1997 July;20(7):1122-7.

(41) Cincotta AH, Meier AH. Bromocriptine (Ergoset) reduces body weight and improves glucose tolerance in obese subjects. Diabetes Care 1996 June;19(6):667-70.

(42) Collis N, Elliot LA, Sharpe C, Sharpe DT. Cellulite treatment: a myth or reality: a prospective randomized, controlled trial of two therapies, endermologie and aminophylline cream. Plast Reconstr Surg 1999 September;104(4):1110-4.

(43) Connacher AA, Bennet WM, Jung RT. Clinical studies with the beta-adrenoceptor agonist BRL 26830A. Am J Clin Nutr 1992 January;55(1 Suppl):258S-61S.

(44) Connacher AA, Jung RT, Mitchell PE. Weight loss in obese subjects on a restricted diet given BRL 26830A, a new atypical beta adrenoceptor agonist. Br Med J (Clin Res Ed) 1988 April 30;296(6631):1217-20.

Abstract: A double blind placebo controlled study was carried out in 40 subjects newly referred for treatment for obesity to determine the effects of the new thermogenic beta adrenoceptor agonist BRL 26830A. The subjects were randomised to receive either BRL 26830A, 200 mg daily for two weeks then 400 mg daily, or placebo for 18 weeks, and all were instructed to follow a 3.35 MJ diet that was low in fat and high in fibre. Weight loss was 15.4 (SD 6.6) kg in subjects given BRL 26830A compared with 10.0 (5.9) kg in those given placebo (p = 0.02). The relative weight loss was 0.93 (0.39%) a week with BRL 26830A and 0.61 (0.38)% with placebo (p = 0.02). Urinary excretion of nitrogen was similar in both groups, whereas measurements of skinfold thickness indicated a 4.1 kg difference in the amount of fat lost, suggesting that weight loss with BRL 26830A was mainly from adipose and not lean tissue. BRL 26830A had no effect on resting pulse rate or pressor effects on either diastolic or systolic blood pressure. No significant differences were found between the two groups in serum cholesterol concentration, percentage of high density lipoprotein cholesterol, plasma concentrations of glucose and insulin, the ratio of glucose to insulin, serum concentrations of triiodothyronine and thyroxine, and creatinine clearance. Short term administration of BRL 26830A to six subjects who had taken the drug for 18 weeks showed that the expenditure of energy increased by 11.6% during the second hour after administration, which suggests that BRL 26830A may enhance weight loss thermogenically. BRL 26830A may be a useful drug in the treatment of obesity

(45) Connolly VM, Gallagher A, Kesson CM. A study of fluoxetine in obese elderly patients with type 2 diabetes. Diabet Med 1995 May;12(5):416-8.

(46) Cook RF, Howard AN, Mills IH. Low-dose mianserin as adjuvant therapy in obese patients treated by a very-low-calorie diet. Int J Obes 1981;5(3):267-72.

Abstract: A double blind trial examined the effects of low doses of the anti-depressant compound mianserin (10 mg nocte, Organon, Oss, Holland) on dietary compliance and weight loss in 45 obese subjects treated by a very-low-calorie diet (VLCD, 320 kcal (1.34 MJ)/day) for 16 weeks. The total mean weight loss of the 25 patients who completed the trial was 15.5 kg +/- 6.1 s.d. There was no significant difference in weight loss between the groups. More patients taking placebo (54 per cent vs 38 per cent) completed the experiment. Three patients stopped mianserin because of drowsiness, but were able to continue on the VLCD alone. Beck rating scores decreased (indicating less depression) in both groups by 50 per cent after eight weeks. With the linear self-rating scale there was no change in the placebo group but the mianserin group reported feeling less depressed (P less than 0.001). No significant changes were observed in ECG and routine clinical and laboratory tests. It is concluded that VLCD can be a safe and acceptable means of achieving substantial weight loss over several months. Patients do not become more depressed during treatment and there is no clinical advantage to be gained by the routine additional use of low doses of mianserin

(47) Cuellar GE, Ruiz AM, Monsalve MC, Berber A. Six-month treatment of obesity with sibutramine 15 mg; a double-blind, placebo-controlled monocenter clinical trial in a Hispanic population. Obes Res 2000 January;8(1):71-82.

(48) Damsbo P, Hermann LS, Vaag A, Hother-Nielsen O, Beck-Nielsen H. Irreversibility of the defect in glycogen synthase activity in skeletal muscle from obese patients with NIDDM treated with diet and metformin. Diabetes Care 1998 September;21(9):1489-94.

(49) Darga LL, Carroll-Michals L, Botsford SJ, Lucas CP. Fluoxetine's effect on weight loss in obese subjects. Am J Clin Nutr 1991 August;54(2):321-5.

(50) Daubresse JC, Kolanowski J, Krzentowski G, Kutnowski M, Scheen A, Van Gaal L. Usefulness of fluoxetine in obese non-insulin-dependent diabetics: a multicenter study. Obes Res 1996 July;4(4):391-6.

(51) Davidson MH, Hauptman J, DiGirolamo M et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial. JAMA 1999 January 20;281(3):235-42.

(52) Davila-Cervantes A, Borunda D, Dominguez-Cherit G et al. Open versus laparoscopic vertical banded gastroplasty: a randomized controlled double blind trial. Obes Surg 2002 December;12(6):812-8.

(53) Ditschuneit HH, Flechtner-Mors M, Adler G. The effects of dexfenfluramine on weight loss and cardiovascular risk factors in female patients with upper and lower body obesity. J Cardiovasc Risk 1996 August;3(4):397-403.

(54) Douglas JG, Gough J, Preston PG et al. Long-term efficacy of fenfluramine in treatment of obesity. Lancet 1983 February 19;1(8321):384-6.

Abstract: 42 obese women who lost at least 6 kg after 26 weeks on fenfluramine tablets had their treatment changed to either an equivalent dose of a sustained-release preparation of fenfluramine or matching placebo in double-blind fashion. Of the 21 given placebo all but 2 regained weight over the following year. Of the 21 crossed over to fenfluramine, 8 maintained their weight loss, 7 regained weight, and 6 had to be withdrawn for reasons other than weight gain. Plasma concentrations of fenfluramine and norfenfluramine taken before and 4 weeks after the crossover were similar in both responders and non-responders, but non-responders did not maintain their drug levels for as long as did the responders. Longer controlled administration of fenfluramine will prevent weight regain in some obese women but the hazards of prolonged use remain to be evaluated

(55) Drent ML, Popp-Snijders C, Ader HJ, Jansen JB, van der Veen EA. Lipase inhibition and hormonal status, body composition and gastrointestinal processing of a liquid high-fat mixed meal in moderately obese subjects. Obes Res 1995 November;3(6):573-81.

(56) Drent ML, Zelissen PM, Koppeschaar HP, Nieuwenhuyzen Kruseman AC, Lutterman JA, van der Veen EA. The effect of dexfenfluramine on eating habits in a Dutch ambulatory android overweight population with an overconsumption of snacks. Int J Obes Relat Metab Disord 1995 May;19(5):299-304.

(57) Drent ML, Larsson I, William-Olsson T et al. Orlistat (Ro 18-0647), a lipase inhibitor, in the treatment of human obesity: a multiple dose study. Int J Obes Relat Metab Disord 1995 April;19(4):221-6.

(58) Drent ML, van der Veen EA. Lipase inhibition: a novel concept in the treatment of obesity. Int J Obes Relat Metab Disord 1993 April;17(4):241-4.

(59) Dujovne CA, Zavoral JH, Rowe E, Mendel CM. Effects of sibutramine on body weight and serum lipids: a double-blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia. Am Heart J 2001 September;142(3):489-97.

(60) Elliott BJ. A double-blind controlled study of the use of diethylpropion hydrochloride (Tenuate) in obese patients in a rural practice. N Z Med J 1978 October 25;88(622):321-2.

Abstract: A double-blind, placebo-controlled, cross-over study has been carried out to compare long-acting diethylpropion hydrochloride (Tenuate Dospan, Wm. S. Merrell Company, hereafter referred to as TD) in a rural general practice. TD was found to produce significantly more weight loss than placebo and side effects were not significantly greater. The need for the treatment of obese patients in general practice is discussed, as is the role of anorexiant therapy

(61) Enzi G, Crepaldi G, Inelmen EM, Bruni R, Baggio B. Efficacy and safety of dexfenfluramine in obese patients: a multicenter study. Clin Neuropharmacol 1988;11 Suppl 1:S173-S178.

Abstract: We have evaluated the effects of dextrofenfluramine treatment on body weight control during a 90 day period, in obese patients on a calorie-restricted diet. The weight loss in dextrofenfluramine-treated patients was significantly higher than in placebo group. The rate of weight loss was linear up to the end of the trial in d-fenfluramine patients. Neural disturbances (vertigo, headache, depression) were the most frequent side effects observed in both the d-fenfluramine and in the placebo-treated groups, without significant differences between the groups. A total number of 23 patients in the dextrofenfluramine group and 20 patients in the placebo group complained side effects. Six patients (five in the d-fenfluramine group and one in the placebo group) discontinued the treatment, due to the side effects. No modifications of the biochemical parameters considered (fasting blood glucose, bilirubin, alkaline phosphatase, creatinine, blood cell counts, asparate-amino transferase (AST), alanine-amino transferase (ALT), total plasma and HDL cholesterol, and triglycerides) were observed at the end of the trial. A significant reduction of total serum cholesterol was observed in both groups at the end of the period of treatment. In conclusion, dextrafenfluramine was proved to be in short term trials an effective and safe tool in overweight control in obese patients

(62) Ettinger MP, Littlejohn TW, Schwartz SL et al. Recombinant variant of ciliary neurotrophic factor for weight loss in obese adults: a randomized, dose-ranging study. JAMA 2003 April 9;289(14):1826-32.

(63) Fanghanel G, Cortinas L, Sanchez-Reyes L, Berber A. Second phase of a double-blind study clinical trial on Sibutramine for the treatment of patients suffering essential obesity: 6 months after treatment cross-over. Int J Obes Relat Metab Disord 2001 May;25(5):741-7.

(64) Fanghanel G, Cortinas L, Sanchez-Reyes L, Berber A. A clinical trial of the use of sibutramine for the treatment of patients suffering essential obesity. Int J Obes Relat Metab Disord 2000 February;24(2):144-50.

(65) Fanghanel G, Cortinas L, Sanchez-Reyes L, Berber A. Second phase of a double-blind study clinical trial on Sibutramine for the treatment of patients suffering essential obesity: 6 months after treatment cross-over. Int J Obes Relat Metab Disord 2001 May;25(5):741-7.

(66) Fanghanel G, Cortinas L, Sanchez-Reyes L, Berber A. A clinical trial of the use of sibutramine for the treatment of patients suffering essential obesity. Int J Obes Relat Metab Disord 2000 February;24(2):144-50.

(67) Faria AN, Ribeiro Filho FF, Lerario DD, Kohlmann N, Ferreira SR, Zanella MT. Effects of sibutramine on the treatment of obesity in patients with arterial hypertension. Arq Bras Cardiol 2002 February;78(2):172-80.

(68) Ferguson JM. Fluoxetine-induced weight loss in overweight, nondepressed subjects. Am J Psychiatry 1986 November;143(11):1496.

(69) Fernandez-Soto ML, Gonzalez-Jimenez A, Barredo-Acedo F, Luna del Castillo JD, Escobar-Jimenez F. Comparison of fluoxetine and placebo in the treatment of obesity. Ann Nutr Metab 1995;39(3):159-63.

(70) Finer N, Bloom SR, Frost GS, Banks LM, Griffiths J. Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: a randomised, double-blind, placebo-controlled study. Diabetes Obes Metab 2000 April;2(2):105-12.

(71) Finer N, James WP, Kopelman PG, Lean ME, Williams G. One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor. Int J Obes Relat Metab Disord 2000 March;24(3):306-13.

(72) Finer N. Body weight evolution during dexfenfluramine treatment after initial weight control. Int J Obes Relat Metab Disord 1992 December;16 Suppl 3:S25-S29.

(73) Finer N, Finer S, Naoumova RP. Drug therapy after very-low-calorie diets. Am J Clin Nutr 1992 July;56(1 Suppl):195S-8S.

(74) Finer N, Craddock D, Lavielle R, Keen H. Effect of 6 months therapy with dexfenfluramine in obese patients: studies in the United Kingdom. Clin Neuropharmacol 1988;11 Suppl 1:S179-S186.

Abstract: The efficacy of dexfenfluramine in inducing weight loss and its clinical acceptability were assessed in two studies carried out in a hospital obesity clinic and general practitioner's office. Seventeen patients who had gained an average of 0.7 +/- 1.9 kg during 12 weeks treatment with diet and placebo lost a mean of 2.9 +/- 0.5 kg after 12 weeks sequential treatment with dexfenfluramine 15 mg twice daily (p less than 0.001). In a second trial, 29 patients treated for 24 weeks with dexfenfluramine showed significantly increased, and continuing, weight loss after 24 weeks (7.0 +/- 0.8 kg) compared to that after 12 weeks of treatment (5.7 +/- 0.1 kg; p = 0.05). The incidence of side effects in both trials was lower than that reported in previous studies of racemic dl-fenfluramine. The clinically significant weight loss and low incidence of unwanted effects suggest that dexfenfluramine has a role in the treatment of refractory obesity

(75) Fujioka K, Seaton TB, Rowe E et al. Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus. Diabetes Obes Metab 2000 June;2(3):175-87.

(76) Gadde KM, Franciscy DM, Wagner HR, Krishnan KR. Zonisamide for weight loss in obese adults: a randomized controlled trial. JAMA 2003 April 9;289(14):1820-5.

(77) Gadde KM, Parker CB, Maner LG et al. Bupropion for weight loss: an investigation of efficacy and tolerability in overweight and obese women. Obes Res 2001 September;9(9):544-51.

(78) Galletly C, Clark A, Tomlinson L. Evaluation of dexfenfluramine in a weight loss program for obese infertile women. Int J Eat Disord 1996 March;19(2):209-12.

(79) Garrow J. Does cimetidine cause weight loss? BMJ 1993 April 24;306(6885):1084.

(80) Geliebter A, Melton PM, Gage D, McCray RS, Hashim SA. Gastric balloon to treat obesity: a double-blind study in nondieting subjects. Am J Clin Nutr 1990 April;51(4):584-8.

Abstract: To determine its efficacy and safety in treating obesity, a silicone-rubber balloon was passed into the stomach of 10 nondieting, obese subjects. In a counterbalanced sequence, the balloon was inflated with 400 mL for 1 mo and deflated for 1 mo. Lower intakes of solid and liquid test meals (NS), significantly slower gastric emptying, and concomitant changes in glucose, insulin, glucagon, and cholecystokinin concentrations consistent with slower emptying resulted during balloon inflation. After balloon inflation, one small gastric ulcer developed, which subsequently healed. Significant weight loss occurred during the second and third week of the inflation period (F[1,9] = 5.0, p less than 0.05). However, the weight loss was small and the significant effect did not continue through the fourth week

(81) Gokcel A, Karakose H, Ertorer EM, Tanaci N, Tutuncu NB, Guvener N. Effects of sibutramine in obese female subjects with type 2 diabetes and poor blood glucose control. Diabetes Care 2001 November;24(11):1957-60.

(82) Goldstein DJ, Rampey AH, Jr., Roback PJ et al. Efficacy and safety of long-term fluoxetine treatment of obesity--maximizing success. Obes Res 1995 November;3 Suppl 4:481S-90S.

(83) Goldstein DJ, Rampey AH, Jr., Enas GG, Potvin JH, Fludzinski LA, Levine LR. Fluoxetine: a randomized clinical trial in the treatment of obesity. Int J Obes Relat Metab Disord 1994 March;18(3):129-35.

(84) Goodall E, Oxtoby C, Richards R, Watkinson G, Brown D, Silverstone T. A clinical trial of the efficacy and acceptability of D-fenfluramine in the treatment of neuroleptic-induced obesity. Br J Psychiatry 1988 August;153:208-13.

Abstract: Twenty-nine overweight schizophrenic patients maintained on depot neuroleptic injections who wished to lose weight took part in a double-blind, placebo-controlled trial of 30 mg D-fenfluramine. All subjects received dietary advice. Sixteen patients completed the 12-week trial. Rate of weight loss was significantly greater in those taking D-fenfluramine. Side-effects were reported, but no deterioration in mental state was noted

(85) Gray DS, Fujioka K, Devine W, Bray GA. A randomized double-blind clinical trial of fluoxetine in obese diabetics. Int J Obes Relat Metab Disord 1992 December;16 Suppl 4:S67-S72.

(86) Gray DS, Fujioka K, Devine W, Bray GA. Fluoxetine treatment of the obese diabetic. Int J Obes Relat Metab Disord 1992 March;16(3):193-8.

(87) Greenway F, Herber D, Raum W, Herber D, Morales S. Double-blind, randomized, placebo-controlled clinical trials with non- prescription medications for the treatment of obesity. Obes Res 1999 July;7(4):370-8.

Abstract: OBJECTIVE: Phenylpropanolamine (PPA) and benzocaine are non- prescription medications approved for treating obesity. The dose of PPA for weight loss is 75 mg/day. PPA has the same chemical similarity to pseudoephedrine that amphetamine has to methamphetamine. Because benzocaine causes weight loss by altering taste and PPA by central appetite suppression, they may induce additional weight loss when combined. These studies explore the safety and efficacy of low-dose PPA, pseudoephedrine, and PPA with benzocaine in causing weight loss. RESEARCH METHODS AND PROCEDURES: Study 1 compared PPA 12.5 mg tid with 25 mg tid and placebo in a 6-week trial in 108 obese subjects. Study 2 compared pseudoephedrine 120 mg/day and a placebo in a 12-week trial with 72 obese subjects. Study 3 compared 4 groups of 20 obese subjects using PPA 75 mg/day, benzocaine gum 96 mg/day, PPA with benzocaine gum, and a placebo over 12 weeks. RESULTS: Both doses of PPA gave twice the weight loss of placebo, but the difference did not reach statistical significance. Pseudoephedrine was no different than placebo in inducing weight loss. The PPA with benzocaine group had more adverse events than the benzocaine group (p = 0.03), the placebo group (p = 0.03), or the PPA group (p = 0.09) without additional weight loss. DISCUSSION: We conclude that further studies with low-dose PPA for weight loss are indicated, that pseudoephedrine is not effective for weight loss, and that adding benzocaine to phenylpropanolamine increases adverse effects without increasing weight loss

(88) Greenway F. A double-blind clinical evaluation of the anorectic activity of phenylpropanolamine versus placebo. Clin Ther 1989 September;11(5):584-9.

Abstract: A double-blind, placebo-controlled 14-week study evaluated the anorectic activity of 75 mg of phenylpropanolamine HCl (PPA) in 102 overweight subjects. Changes in weight and vital signs were monitored at two-week intervals. Eighty-five subjects, 90% of the PPA group and 83% of the placebo group, completed the study. The PPA group consistently showed significantly greater weight loss than the placebo group after 6, 8, 10, 12, and 14 weeks of the study. The only significant change in vital signs was a rise in diastolic blood pressure noted at week 12 in the PPA group, but this change was small (3.43 mmHg) and considered clinically insignificant. Overall, 75 mg of PPA was associated with significant weight loss as early as week 6 of the study and was shown to be a superior anorexiant in comparison with placebo

(89) Greenway FL, Raum WJ, DeLany JP. The effect of an herbal dietary supplement containing ephedrine and caffeine on oxygen consumption in humans. J Altern Complement Med 2000 December;6(6):553-5.

(90) Gropper SS, Acosta PB. The therapeutic effect of fiber in treating obesity. J Am Coll Nutr 1987 December;6(6):533-5.

Abstract: This study provides preliminary data on the influence of ingestion of 15 g of dietary fiber daily for 4 weeks on weight change and serum iron concentrations in obese children. During two consecutive 4-week periods, subjects received either fiber/placebo supplements or placebo/fiber supplements. Initially, and after the fourth and eighth weeks, height, weight, and serum iron concentration were obtained. Diet records were maintained throughout the study. No significant differences (p less than or equal to 0.05) were found in weight change, energy, iron, and crude fiber intakes and serum iron concentrations of the subjects between periods of fiber and placebo supplementation. However, mean weight loss of subjects (336 g) was greater during fiber ingestion than during placebo ingestion (33 g). Due to the small sample size and the subjects' poor compliance, further studies are needed, with a larger sample size, to determine the effectiveness of different fibers in the treatment of obesity

(91) Guy-Grand B, Apfelbaum M, Crepaldi G, Gries A, Lefebvre P, Turner P. International trial of long-term dexfenfluramine in obesity. Lancet 1989 November 11;2(8672):1142-5.

Abstract: In a randomised, placebo-controlled, double-blind study, 822 obese patients of both sexes were given either dexfenfluramine (dF), 15 mg twice daily (404), or placebo (418) in addition to a calorie-restricted diet for 1 year. Patients in both groups lost weight significantly in the first 6 months; after 6 months dF patients had a higher cumulative mean weight loss. Dropout rates were lower in dF patients than in placebo patients, mainly because of dissatisfaction with weight loss in the latter group. More than twice as many dF patients as placebo patients achieved a given weight loss; but more dF patients than placebo patients had transient side-effects (tiredness, diarrhoea, dry mouth, polyuria, and drowsiness)

(92) Gwirtsman H, Kaye W, Weintraub M, Jimerson DC. Pharmacologic treatment of eating disorders. Psychiatr Clin North Am 1984 December;7(4):863-78.

Abstract: Increased research focusing on the eating disorders has put the clinician on firmer ground when choosing appropriate psychopharmacologic treatments. Recent studies of patients with bulimia demonstrate that treatment with antidepressant medications may substantially reduce symptoms of bingeing and vomiting. The efficacy of pharmacologic approaches to anorexia nervosa is more uncertain, in part because of the limited availability of long-term follow-up studies. The judicious use of appetite suppressant medications, as reviewed in the text, is helpful for mild to moderate obesity. In treating these disorders, the clinician needs to integrate medication treatment with psychotherapeutic and behavioral treatment approaches

(93) Halpern A, Mancini MC, Suplicy H et al. Latin-American trial of orlistat for weight loss and improvement in glycaemic profile in obese diabetic patients. Diabetes Obes Metab 2003 May;5(3):180-8.

(94) Halpern A, Leite CC, Herszkowicz N, Barbato A, Costa AP. Evaluation of efficacy, reliability, and tolerability of sibutramine in obese patients, with an echocardiographic study. Rev Hosp Clin Fac Med Sao Paulo 2002 May;57(3):98-102.

(95) Hanefeld M, Sachse G. The effects of orlistat on body weight and glycaemic control in overweight patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes Obes Metab 2002 November;4(6):415-23.

(96) Hanotin C, Thomas F, Jones SP, Leutenegger E, Drouin P. A comparison of sibutramine and dexfenfluramine in the treatment of obesity. Obes Res 1998 July;6(4):285-91.

(97) Hanotin C, Thomas F, Jones SP, Leutenegger E, Drouin P. Efficacy and tolerability of sibutramine in obese patients: a dose-ranging study. Int J Obes Relat Metab Disord 1998 January;22(1):32-8.

(98) Hansen D, Astrup A, Toubro S et al. Predictors of weight loss and maintenance during 2 years of treatment by sibutramine in obesity. Results from the European multi-centre STORM trial. Sibutramine Trial of Obesity Reduction and Maintenance. Int J Obes Relat Metab Disord 2001 April;25(4):496-501.

(99) Hansen DL, Toubro S, Stock MJ, Macdonald IA, Astrup A. The effect of sibutramine on energy expenditure and appetite during chronic treatment without dietary restriction. Int J Obes Relat Metab Disord 1999 October;23(10):1016-24.

(100) Haslett C, Douglas JG, Chalmers SR, Weighhill A, Munro JF. A double-blind evaluation of evening primrose oil as an antiobesity agent. Int J Obes 1983;7(6):549-53.

Abstract: Evening Primrose Oil (EPO) is a naturally occurring rich source of essential fatty acids, especially linoleic and gamma-linolenic acid. It has been suggested that it has antiobesity properties. This double-blind 12-week study was undertaken in 100 women with substantial obesity: 40 with refractory obesity, and 60 at time of initial referral to a hospital clinic. Seventy-four subjects completed the study. Those treated with EPO were comparable in age and degree of obesity with the placebo-treated group. There was no significant difference in the weight loss achieved by those taking EPO compared with placebo, either in the subjects with refractory obesity or in those treated at time of initial referral. It would appear that any antiobesity property possessed by EPO is clinically insignificant

(101) Haugen HN. Double blind cross-over study of a new appetite suppressant AN 448. Eur J Clin Pharmacol 1975;8(1):71-4.

Abstract: The effects of a new appetite suppressant, AN 448, and a placebo have been compared in 30 obese individuals using a fully randomized double-blind cross-over design. 1 mg of AN 448 t.i.d. produced a significant degree of appetite suppression and a mean weight loss of more than 4 kg per individual over a 6 week period. Side effects were few and no haematological, renal or hepatic damage was observed

(102) Hauner H, Petzinna D, Sommerauer B, Toplak H. Effect of acarbose on weight maintenance after dietary weight loss in obese subjects. Diabetes Obes Metab 2001 December;3(6):423-7.

(103) Hauptman J, Lucas C, Boldrin MN, Collins H, Segal KR. Orlistat in the long-term treatment of obesity in primary care settings. Arch Fam Med 2000 February;9(2):160-7.

(104) Hazenberg BP. Randomized, double-blind, placebo-controlled, multicenter study of sibutramine in obese hypertensive patients. Cardiology 2000;94(3):152-8.

(105) Heini AF, Lara-Castro C, Schneider H, Kirk KA, Considine RV, Weinsier RL. Effect of hydrolyzed guar fiber on fasting and postprandial satiety and satiety hormones: a double-blind, placebo-controlled trial during controlled weight loss. Int J Obes Relat Metab Disord 1998 September;22(9):906-9.

(106) Heymsfield SB, Segal KR, Hauptman J et al. Effects of weight loss with orlistat on glucose tolerance and progression to type 2 diabetes in obese adults. Arch Intern Med 2000 May 8;160(9):1321-6.

(107) Heymsfield SB, Greenberg AS, Fujioka K et al. Recombinant leptin for weight loss in obese and lean adults: a randomized, controlled, dose-escalation trial. JAMA 1999 October 27;282(16):1568-75.

(108) Heymsfield SB, Allison DB, Vasselli JR, Pietrobelli A, Greenfield D, Nunez C. Garcinia cambogia (hydroxycitric acid) as a potential antiobesity agent: a randomized controlled trial. JAMA 1998 November 11;280(18):1596-600.

(109) Hill JO, Hauptman J, Anderson JW et al. Orlistat, a lipase inhibitor, for weight maintenance after conventional dieting: a 1-y study. Am J Clin Nutr 1999 June;69(6):1108-16.

(110) Hoeger WW, Harris C, Long EM, Hopkins DR. Four-week supplementation with a natural dietary compound produces favorable changes in body composition. Adv Ther 1998 September;15(5):305-14.

(111) Hogan RB, Johnston JH, Long BW et al. A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. Gastrointest Endosc 1989 September;35(5):381-5.

Abstract: We investigated the effect of an endoscopically placed gastric balloon, the Garren-Edwards gastric bubble (GEGB), on weight loss in obese patients. Fifty-nine obese patients were entered into a prospective double-blind study and randomized into two groups. In one group (34 patients) the GEGB was inserted, and in the other group (25 patients) a sham insertion was done. All patients participated in a standard weight loss program consisting of dietary therapy, behavior modification, and physical exercise. The bubble was removed endoscopically after 3 months from both groups. Patients were followed for an additional 9 months after bubble removal and weight loss was monitored. Weight loss was the same in both groups at 3 months (18.7 lb vs. 17.2 lb). This was true whether determined by change in pounds, percentage of body weight, or body mass index. We concluded that the GEGB was of no added benefit as compared with sham insertion, when combined with a standard weight loss program. Because of the lack of proven efficacy and the relatively high cost, we recommend that such devices be restricted to controlled studies until significant benefits are proven

(112) Holdaway IM, Wallace E, Westbrooke L, Gamble G. Effect of dexfenfluramine on body weight, blood pressure, insulin resistance and serum cholesterol in obese individuals. Int J Obes Relat Metab Disord 1995 October;19(10):749-51.

(113) Hollander PA, Elbein SC, Hirsch IB et al. Role of orlistat in the treatment of obese patients with type 2 diabetes. A 1-year randomized double-blind study. Diabetes Care 1998 August;21(8):1288-94.

(114) Holman SL, Goldstein DJ, Enas GG. Pattern analysis method for assessing successful weight reduction. Int J Obes Relat Metab Disord 1994 May;18(5):281-5.

(115) Hukshorn CJ, Westerterp-Plantenga MS, Saris WH. Pegylated human recombinant leptin (PEG-OB) causes additional weight loss in severely energy-restricted, overweight men. Am J Clin Nutr 2003 April;77(4):771-6.

(116) Hukshorn CJ, van Dielen FM, Buurman WA, Westerterp-Plantenga MS, Campfield LA, Saris WH. The effect of pegylated recombinant human leptin (PEG-OB) on weight loss and inflammatory status in obese subjects. Int J Obes Relat Metab Disord 2002 April;26(4):504-9.

(117) Hukshorn CJ, Saris WH, Westerterp-Plantenga MS, Farid AR, Smith FJ, Campfield LA. Weekly subcutaneous pegylated recombinant native human leptin (PEG-OB) administration in obese men. J Clin Endocrinol Metab 2000 November;85(11):4003-9.

(118) Jain AK, Kaplan RA, Gadde KM et al. Bupropion SR vs. placebo for weight loss in obese patients with depressive symptoms. Obes Res 2002 October;10(10):1049-56.

(119) James WP, Astrup A, Finer N et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance. Lancet 2000 December 23;356(9248):2119-25.

(120) James WP, Avenell A, Broom J, Whitehead J. A one-year trial to assess the value of orlistat in the management of obesity. Int J Obes Relat Metab Disord 1997 June;21 Suppl 3:S24-S30.

(121) Johnson WG, Hughes JR. Mazindol: its efficacy and mode of action in generating weight loss. Addict Behav 1979;4(3):237-44.

(122) Jonderko K, Kucio C. Effect of anti-obesity drugs promoting energy expenditure, yohimbine and ephedrine, on gastric emptying in obese patients. Aliment Pharmacol Ther 1991 August;5(4):413-8.

(123) Kalman D, Incledon T, Gaunaurd I, Schwartz H, Krieger D. An acute clinical trial evaluating the cardiovascular effects of an herbal ephedra-caffeine weight loss product in healthy overweight adults. Int J Obes Relat Metab Disord 2002 October;26(10):1363-6.

(124) Kalman D, Incledon T, Gaunaurd I, Schwartz H, Krieger D. An acute clinical trial evaluating the cardiovascular effects of an herbal ephedra-caffeine weight loss product in healthy overweight adults. Int J Obes Relat Metab Disord 2002 October;26(10):1363-6.

(125) Karhunen L, Franssila-Kallunki A, Rissanen P et al. Effect of orlistat treatment on body composition and resting energy expenditure during a two-year weight-reduction programme in obese Finns. Int J Obes Relat Metab Disord 2000 December;24(12):1567-72.

(126) Kelley DE, Bray GA, Pi-Sunyer FX et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: A 1-year randomized controlled trial. Diabetes Care 2002 June;25(6):1033-41.

(127) Hoeger WW, Harris C, Long EM, Hopkins DR. Four-week supplementation with a natural dietary compound produces favorable changes in body composition. Adv Ther 1998 September;15(5):305-14.

(128) Kelley DE, Bray GA, Pi-Sunyer FX et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: A 1-year randomized controlled trial. Diabetes Care 2002 June;25(6):1033-41.

(129) Kim KR, Nam SY, Song YD, Lim SK, Lee HC, Huh KB. Low-dose growth hormone treatment with diet restriction accelerates body fat loss, exerts anabolic effect and improves growth hormone secretory dysfunction in obese adults. Horm Res 1999;51(2):78-84.

(130) Kovacs EM, Westerterp-Plantenga MS, de Vries M, Brouns F, Saris WH. Effects of 2-week ingestion of (-)-hydroxycitrate and (-)-hydroxycitrate combined with medium-chain triglycerides on satiety and food intake. Physiol Behav 2001 November;74(4-5):543-9.

(131) Krempf M, Louvet JP, Allanic H, Miloradovich T, Joubert JM, Attali JR. Weight reduction and long-term maintenance after 18 months treatment with orlistat for obesity. Int J Obes Relat Metab Disord 2003 May;27(5):591-7.

(132) Kriketos AD, Thompson HR, Greene H, Hill JO. (-)-Hydroxycitric acid does not affect energy expenditure and substrate oxidation in adult males in a post-absorptive state. Int J Obes Relat Metab Disord 1999 August;23(8):867-73.

(133) Kucio C, Jonderko K, Piskorska D. Does yohimbine act as a slimming drug? Isr J Med Sci 1991 October;27(10):550-6.

(134) Kutnowski M, Daubresse JC, Friedman H et al. Fluoxetine therapy in obese diabetic and glucose intolerant patients. Int J Obes Relat Metab Disord 1992 December;16 Suppl 4:S63-S66.

(135) Laaksonen DE, Nuutinen J, Lahtinen T, Rissanen A, Niskanen LK. Changes in abdominal subcutaneous fat water content with rapid weight loss and long-term weight maintenance in abdominally obese men and women. Int J Obes Relat Metab Disord 2003 June;27(6):677-83.

(136) Laederach-Hofmann K, Graf C, Horber F et al. Imipramine and diet counseling with psychological support in the treatment of obese binge eaters: a randomized, placebo-controlled double-blind study. Int J Eat Disord 1999 November;26(3):231-44.

(137) Lafreniere F, Lambert J, Rasio E, Serri O. Effects of dexfenfluramine treatment on body weight and postprandial thermogenesis in obese subjects. A double-blind placebo-controlled study. Int J Obes Relat Metab Disord 1993 January;17(1):25-30.

(138) Lawton CL, Wales JK, Hill AJ, Blundell JE. Serotoninergic manipulation, meal-induced satiety and eating pattern: effect of fluoxetine in obese female subjects. Obes Res 1995 July;3(4):345-56.

(139) Lee A, Morley JE. Metformin decreases food consumption and induces weight loss in subjects with obesity with type II non-insulin-dependent diabetes. Obes Res 1998 January;6(1):47-53.

(140) Leibel RL, Drewnowski A, Hirsch J. Effect of glycerol on weight loss and hunger in obese patients. Metabolism 1980 December;29(12):1234-6.

Abstract: The effectiveness of oral glycerol as a dietary component or as a supplement to a 1000-kcal/day diet was examined in two studies involving obese patients. Glycerol did not differ from an equicaloric dose of glucose in its effect on hunger ratings, diet compliance or overall weight loss. We conclude that oral glycerol is not a useful adjunct to weight reduction programs

(141) Lindgarde F. The effect of orlistat on body weight and coronary heart disease risk profile in obese patients: the Swedish Multimorbidity Study. J Intern Med 2000 September;248(3):245-54.

(142) Lindor KD, Hughes RW, Jr., Ilstrup DM, Jensen MD. Intragastric balloons in comparison with standard therapy for obesity--a randomized, double-blind trial. Mayo Clin Proc 1987 November;62(11):992-6.

Abstract: Intragastric balloons are new but commonly used devices for the treatment of obesity; however, their safety and efficacy have not been established. We report our results of a small, double-blind, randomized trial in which the effectiveness of intragastric balloons was compared with that of conventional medical therapy for obesity. Twenty-two patients, who were 21 to 77% over ideal body weight, were studied. Eleven underwent insertion of an intragastric balloon, and 11 underwent sham procedures. One patient with a gastric balloon withdrew from the study after 3 days. Weight loss at 2 to 3 months in the conventional therapy group averaged 2.8 kg; in the balloon-treated group, the mean weight loss was 5.8 kg (P greater than 0.15). Of the 10 balloons, 8 spontaneously deflated, and 1 was passed in the stools. We noted gastric erosions in five patients and multiple gastric ulcers in one. We conclude that the intragastric balloon was not clearly effective in inducing weight loss, had a high rate of spontaneous deflation, and was damaging to the gastric mucosa. Controlled trials should be done before similar weight-reduction devices are used in routine clinical practice

(143) Louvet JP. [Isomeride and treatment of overweight]. Ann Med Interne (Paris) 1989;140 Suppl 1:17-21.

Abstract: Controlled European studies of 1 315 patients in medium (3 month) and long term (6 month, 1 year) trials have shown the efficacy and safety of Isomeride in the treatment of overweight. Three month studies of Isomeride plus diet versus placebo plus diet have shown an average weight loss of 3 kilograms in the first month and 7 kilograms after 3 months treatment in the Isomeride group. The difference with placebo was significant in the first month and increased in the following months. Drop out was similar in both groups. The safety of Isomeride made possible long term treatment of particularly severe refractory cases of overweight. A 6 month English trial confirmed these results and a research programme is underway to assess the value of 1 year and more therapy with Isomeride

(144) Lovejoy JC, Bray GA, Greeson CS et al. Oral anabolic steroid treatment, but not parenteral androgen treatment, decreases abdominal fat in obese, older men. Int J Obes Relat Metab Disord 1995 September;19(9):614-24.

(145) MacLachlan M, Connacher AA, Jung RT. Psychological aspects of dietary weight loss and medication with the atypical beta agonist BRL 26830A in obese subjects. Int J Obes 1991 January;15(1):27-35.

Abstract: Psychological aspects of dieting, including hunger and satiety sensations were explored in obese subjects during a placebo-controlled trial of the weight reducing potential of BRL 26830A, a thermogenic beta-3-agonist drug. Successful weight loss was associated with a reduction in the severity of reported depression. The initial degree of emotional disturbance and level of learned resourcefulness appeared to influence the subsequent weight lost. Subjects described few specific hunger and satiety sensations and these sensations did not generally alter during the trial. BRL 26830A, which promoted weight loss, did not significantly influence hunger and satiety sensations and was not associated with emotional disturbances during dieting. With BRL 26830A there was a reduction in the reported somatic symptoms of anxiety which was not apparent on placebo. These results suggest that the subjects' initial psychological state influences outcome when dieting and also that dynamic changes in psychological parameters occur with successful weight loss. Further, BRL 26830A had no effect on appetite and no adverse influence on the psychological functions tested during this study

(146) Maheux P, Ducros F, Bourque J, Garon J, Chiasson JL. Fluoxetine improves insulin sensitivity in obese patients with non-insulin-dependent diabetes mellitus independently of weight loss. Int J Obes Relat Metab Disord 1997 February;21(2):97-102.

(147) Maki KC, Davidson MH, Tsushima R et al. Consumption of diacylglycerol oil as part of a reduced-energy diet enhances loss of body weight and fat in comparison with consumption of a triacylglycerol control oil. Am J Clin Nutr 2002 December;76(6):1230-6.

(148) Marcus MD, Wing RR, Ewing L, Kern E, McDermott M, Gooding W. A double-blind, placebo-controlled trial of fluoxetine plus behavior modification in the treatment of obese binge-eaters and non-binge-eaters. Am J Psychiatry 1990 July;147(7):876-81.

Abstract: To determine whether fluoxetine is effective in the long-term treatment of obesity and whether it is particularly useful in the treatment of obese binge-eaters, the authors randomly assigned 45 obese subjects (22 with binge-eating problems and 23 without binge-eating) to fluoxetine (60 mg/day) or placebo in a 52-week double-blind trial. The 21 subjects who completed the trial made 13 clinic visits and were taught basic behavior modification strategies. Patients treated with fluoxetine plus behavior modification lost significantly more weight than those treated with placebo plus behavior modification. However, the drug did not appear to have a differential benefit for binge-eaters

(149) Marks JW, Bonorris GG, Schoenfield LJ. Roles of deoxycholate and arachidonate in pathogenesis of cholesterol gallstones in obese patients during rapid loss of weight. Dig Dis Sci 1991 July;36(7):957-60.

(150) Mathus-Vliegen EM, Tygat GN. Gastro-oesophageal reflux in obese subjects: influence of overweight, weight loss and chronic gastric balloon distension. Scand J Gastroenterol 2002 November;37(11):1246-52.

(151) Mathus-Vliegen EM. Prolonged surveillance of dexfenfluramine in severe obesity. Neth J Med 1993 December;43(5-6):246-53.

(152) Mathus-Vliegen EM, Tytgat GN, Veldhuyzen-Offermans EA. Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon. Gastroenterology 1990 August;99(2):362-9.

Abstract: A prolonged randomized, prospective, double-blind, crossover study, including a sham-sham-treated group, was undertaken to evaluate the efficacy and safety of a 500-mL gastric bubble (Ballobes; DOT ApS, Rodovre, Denmark) as an adjunct to diet, physical training, and behavioral modification. Only supermorbidly obese patients who fulfilled the usual criteria for surgery were admitted. A weight loss of 38 kg in the first 17 weeks and another 12 kg in the second 18 weeks could be achieved. The body mass index, the percentage of overweight and the loss in percentage of initial weight, paralleled this impressive weight loss. In the second period, a plateau effect occurred after the massive changes in the first period, and only one third of the changes in all parameters was seen. Stratification into a sham-sham, sham-balloon, balloon-sham, and balloon-balloon group did not show any statistical difference for all parameters between the four groups. The double-blind nature of the study was affirmed by the patient's correct judgment of the presence or absence of a balloon in only 21% of the balloon and 44% of the sham procedures. Gastrointestinal complications were infrequent and consisted of erosions (three patients), asymptomatic reflux oesophagitis (one patient), and asymptomatic gastric ulcer (one patient). Only the latter patient had elevated gastrin levels. One patient could not tolerate the balloon. All balloons remained airtight during both parts of the study for a mean of 123 days. This study confirmed the safety of the balloon, but no additional benefit could be ascribed to the balloon compared with a very low-calorie diet and medical and dietary support

(153) Mattes RD, Bormann LA. Reduced dietary underrecording with concurrent tracking of hunger. J Am Diet Assoc 2001 May;101(5):578-80.

(154) Mattes RD, Bormann L. Effects of (-)-hydroxycitric acid on appetitive variables. Physiol Behav 2000 October 1;71(1-2):87-94.

(155) Maughan KL. Does sibutramine keep the weight off? J Fam Pract 1999 June;48(6):420.

(156) McElroy SL, Arnold LM, Shapira NA et al. Topiramate in the treatment of binge eating disorder associated with obesity: a randomized, placebo-controlled trial. Am J Psychiatry 2003 February;160(2):255-61.

(157) McMahon FG, Weinstein SP, Rowe E, Ernst KR, Johnson F, Fujioka K. Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibitors. J Hum Hypertens 2002 January;16(1):5-11.

(158) McMahon FG, Fujioka K, Singh BN et al. Efficacy and safety of sibutramine in obese white and African American patients with hypertension: a 1-year, double-blind, placebo-controlled, multicenter trial. Arch Intern Med 2000 July 24;160(14):2185-91.

(159) McNulty SJ, Ur E, Williams G. A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin. Diabetes Care 2003 January;26(1):125-31.

(160) Mendez-Sanchez N, Gonzalez V, Aguayo P et al. Fish oil (n-3) polyunsaturated fatty acids beneficially affect biliary cholesterol nucleation time in obese women losing weight. J Nutr 2001 September;131(9):2300-3.

(161) Meshkinpour H, Hsu D, Farivar S. Effect of gastric bubble as a weight reduction device: a controlled, crossover study. Gastroenterology 1988 September;95(3):589-92.

Abstract: In spite of the widespread use of the Garren-Edwards gastric bubble as an adjuvant device in weight reduction, its efficacy has not been established. Therefore, our purpose was to conduct a randomized, double-blind, crossover study of this device in the management of exogenous obesity. The study group consisted of 23 patients, 21 women and 2 men, ranging in age from 21 to 53 yr. Patients were 25%-111% above their ideal body weight. They were studied for 24 wk, consisting of two separate 12-wk evaluation periods. Patients were randomly assigned either to receive the gastric bubble or to have a sham procedure. After the first 12-wk evaluation period, the gastric bubble and sham were administered in crossover fashion, so that those who had received the gastric bubble initially received the sham later and vice versa. The study coordinator remained blind to the kind of treatment, weighed each patient biweekly, enforced dietary counseling, and provided behavior modification. Those who had passed or were found to have a deflated bubble at the end of the treatment period were excluded from the study. Mean weight reduction in the two evaluation periods did not differ significantly. Patients lost 5.4 +/- 1.7 kg (mean +/- SE) during the gastric bubble period and 5.20 +/- 0.8 kg during the sham period. The order of administration of the gastric bubble and sham did not significantly affect the result. The time-course of mean biweekly values, however, revealed that with the gastric bubble, weight loss was significantly greater only during first (p less than 0.005) and second (p less than 0.025) 2-wk evaluation periods. This difference, however, disappeared after the initial 4 wk of treatment. These observations suggest that although gastric bubble implantation reduced weight significantly more than the sham procedure initially, the mean weight loss during 12 wk of evaluation was not different between the two periods. In our opinion, the gastric bubble is of no value as an adjuvant device in weight reduction

(162) Micic D, Ivkovic-Lazar T, Dragojevic R, Jorga J, Stokic E, Hajdukovic Z. Orlistat, a gastrointestinal lipase inhibitor, in therapy of obesity with concomitant hyperlipidemia. Med Pregl 1999 September;52(9-10):323-33.

(163) Miles JM, Leiter L, Hollander P et al. Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin. Diabetes Care 2002 July;25(7):1123-8.

(164) Mitchell JE, Morley JE, Levine AS, Hatsukami D, Gannon M, Pfohl D. High-dose naltrexone therapy and dietary counseling for obesity. Biol Psychiatry 1987 January;22(1):35-42.

Abstract: There is considerable evidence that antagonism of the endogenous opioids will suppress food intake in a variety of animal species. The authors report a double-blind, placebo-controlled trial of the long-acting, orally active narcotic antagonist naltrexone in the promotion of weight loss in obese male subjects who were also undergoing dietary counseling for weight reduction. Subjects received medication (naltrexone, 300 mg/day or placebo) for 8 weeks following an initial 2-week single-blind placebo phase. The results failed to demonstrate an advantage for the active drug. However, the naltrexone was associated with hepatotoxicity when used at this dosage in this population

(165) Molnar D, Torok K, Erhardt E, Jeges S. Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents. Int J Obes Relat Metab Disord 2000 December;24(12):1573-8.

(166) Moreira Andres MN, Canizo Gomez FJ, Aracama Montaner JJ. [The relation between serum thyroid hormone concentration and weight loss in obese patients treated with a low-calorie diet]. Rev Clin Esp 1982 December 31;167(6):375-9.

(167) Morgan JP, Funderburk FR. Invited commentary: phenylpropanolamine and the medical literature: a thorough reading is required. Int J Obes 1990 July;14(7):569-74.

(168) Moscucci M, Byrne L, Weintraub M, Cox C. Blinding, unblinding, and the placebo effect: an analysis of patients' guesses of treatment assignment in a double-blind clinical trial. Clin Pharmacol Ther 1987 March;41(3):259-65.

Abstract: We administered a questionnaire to assess maintenance of patients' blindness at the end of a double-blind clinical trial of Osmotic Release Oral System phenylpropanolamine (PPA) vs. placebo in mild obesity. Seventy-four percent of placebo participants and 43% of PPA participants guessed their treatment correctly. Appetite control was the most frequently reported basis for guessing PPA, even by placebo participants. Lack of adverse drug reactions was the most frequently reported basis for guessing placebo, even by PPA participants. Participants receiving either PPA or placebo and guessing PPA lost more weight, had less diet difficulty, and had more adverse drug reactions than had participants receiving either PPA or placebo and guessing placebo. Although blindness was probably maintained in the PPA group, the placebo group seems to have been, at least at the study's end, unblinded. These results suggest that in double-blind studies, differences in outcome or incidence of adverse drug reactions may act as unblinding factors

(169) Muls E, Kolanowski J, Scheen A, Van Gaal L. The effects of orlistat on weight and on serum lipids in obese patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled, multicentre study. Int J Obes Relat Metab Disord 2001 November;25(11):1713-21.

(170) Muth H, Issmeier G. [Weight loss by treatment with Fugoa depot. Results of a double blind study]. Ther Ggw 1980 October;119(10):1173-83.

(171) Naylor GJ, Grant L, Smith C. A double blind placebo controlled trial of ascorbic acid in obesity. Nutr Health 1985;4(1):25-8.

Abstract: A double blind placebo controlled trial of ascorbic acid was carried out in 41 severely obese subjects. 38 patients completed the 6 week trial. 19 received 3g of ascorbic acid per day, 19 received placebo. The weight loss during the trial was small in both groups but was significantly greater in the ascorbic acid treated group

(172) Nazar K, Kaciuba-Uscilko H, Szczepanik J et al. Phosphate supplementation prevents a decrease of triiodothyronine and increases resting metabolic rate during low energy diet. J Physiol Pharmacol 1996 June;47(2):373-83.

(173) O'Connor HT, Richman RM, Steinbeck KS, Caterson ID. Dexfenfluramine treatment of obesity: a double blind trial with post trial follow up. Int J Obes Relat Metab Disord 1995 March;19(3):181-9.

(174) O'Kane M, Wiles PG, Wales JK. Fluoxetine in the treatment of obese type 2 diabetic patients. Diabet Med 1994 January;11(1):105-10.

(175) Oppert JM, Lahlou N, Laferrere B, Roger M, Basdevant A, Guy-Grand B. Plasma leptin and acute serotoninergic stimulation of the corticotropic axis in women who are normal weight or obese. Obes Res 1997 September;5(5):410-6.

(176) Pace DG, Blotner S, Guerciolini R. Short-term orlistat treatment does not affect mineral balance and bone turnover in obese men. J Nutr 2001 June;131(6):1694-9.

(177) Paranjpe P, Patki P, Patwardhan B. Ayurvedic treatment of obesity: a randomised double-blind, placebo-controlled clinical trial. J Ethnopharmacol 1990 April;29(1):1-11.

Abstract: Seventy obese subjects were randomised into four groups. Ayurvedic drug treatments were given for three months while one group received a placebo. Physical, clinical and pathological investigations were carried out at regular intervals. A significant weight loss was observed in drug therapy groups when compared with the placebo. Body measurements such as skin fold thickness and hip and waist circumferences were significantly decreased. Decreases in serum cholesterol and triglyceride levels were observed. No side effects of any kind were observed during the treatment period

(178) Parsons WB, Jr. Controlled-release diethylpropion hydrochloride used in a program for weight reduction. Clin Ther 1981;3(5):329-35.

Abstract: In a double-blind, placebo-controlled evaluation in obese adults given comparable dietary and exercise recommendations, controlled-release diethylpropion hydrochloride promoted significantly more weight loss than matching placebo. The mean reduction in 12 weeks was 15.9 lb (average 1.32 lb/week) for 12 patients taking diethylpropion hydrochloride, 10.0 lb (0.84 lb/week) for 13 taking placebo, and 12.2 lb for 13 taking drug for two four-week periods separated by four weeks of placebo (1.38 lb/week on active drug and 0.30 lb/week on placebo). Amphetamine-like side effects were virtually absent. Diethylpropion hydrochloride is an effective adjunct to caloric restriction in therapy of obesity

(179) Pasquali R, Casimirri F, Melchionda N et al. Effects of chronic administration of ephedrine during very-low-calorie diets on energy expenditure, protein metabolism and hormone levels in obese subjects. Clin Sci (Lond) 1992 January;82(1):85-92.

(180) Pasquali R, Gambineri A, Biscotti D et al. Effect of long-term treatment with metformin added to hypocaloric diet on body composition, fat distribution, and androgen and insulin levels in abdominally obese women with and without the polycystic ovary syndrome. J Clin Endocrinol Metab 2000 August;85(8):2767-74.

(181) Pasquali R, Casimirri F, Melchionda N et al. Effects of chronic administration of ephedrine during very-low-calorie diets on energy expenditure, protein metabolism and hormone levels in obese subjects. Clin Sci (Lond) 1992 January;82(1):85-92.

(182) Pasquali R, Cesari MP, Melchionda N, Stefanini C, Raitano A, Labo G. Does ephedrine promote weight loss in low-energy-adapted obese women? Int J Obes 1987;11(2):163-8.

Abstract: A double-blind cross-over randomized study was performed in 10 selected adult overweight and obese (body mass index greater than 27) women who had been adapted to low-energy intake for a long period of time and who had shown difficulty in losing weight with conventional hypocaloric treatment. Combined with diet therapy (1000-1400 kcal/day), l(-)ephedrine hydrochloride (50 mg three times a day per os) or placebo were administered daily before each meal, after a period of stabilization with diet only for 1 month. Each pharmacological treatment lasted for 2 months. Weight loss was significantly (P less than 0.05) greater during the ephedrine period (2.41 +/- 0.61 kg) than during the placebo period (0.64 +/- 0.50 kg). None of the patients presented clinically important side-effects. These preliminary results seem to suggest a possible role for a thermogenic compound such as ephedrine in promoting weight loss in low-energy-adapted obese women

(183) Pasquali R, Baraldi G, Cesari MP et al. A controlled trial using ephedrine in the treatment of obesity. Int J Obes 1985;9(2):93-8.

Abstract: A double-blind controlled study was performed in unselected obese outpatients to assess the effects of ephedrine on weight loss. Patients were treated for 3 months with placebo (group I), 25 mg t.i.d. or 50 mg t.i.d. of ephedrine hydrochloride orally administered (groups II and III, respectively). Dietary treatment consisted of 1000 kcal/day for females and 1200 kcal/day for males. The three groups were matched for age, sex, body mass index and pre-treatment spontaneous caloric intake. Weight loss was similar in all groups. Patients in group III (ephedrine 150 mg/day) showed significantly more side effects than the placebo group. These results do not seem to favour the hypothesis that ephedrine, a thermogenic agent, may be effective in the therapy of unselected simple obesity. On the other hand, it cannot be excluded that the drug may be useful in obese patients in whom defective thermogenesis may be clearly demonstrated

(184) Pedersen SB, Borglum JD, Kristensen K et al. Regulation of uncoupling protein (UCP) 2 and 3 in adipose and muscle tissue by fasting and growth hormone treatment in obese humans. Int J Obes Relat Metab Disord 2000 August;24(8):968-75.

(185) Peterson CM, Jovanovic-Peterson L. Randomized crossover study of 40% vs. 55% carbohydrate weight loss strategies in women with previous gestational diabetes mellitus and non-diabetic women of 130-200% ideal body weight. J Am Coll Nutr 1995 August;14(4):369-75.

(186) Pedersen SB, Borglum JD, Kristensen K et al. Regulation of uncoupling protein (UCP) 2 and 3 in adipose and muscle tissue by fasting and growth hormone treatment in obese humans. Int J Obes Relat Metab Disord 2000 August;24(8):968-75.

(187) Peterson CM, Jovanovic-Peterson L. Randomized crossover study of 40% vs. 55% carbohydrate weight loss strategies in women with previous gestational diabetes mellitus and non-diabetic women of 130-200% ideal body weight. J Am Coll Nutr 1995 August;14(4):369-75.

(188) Pijl H, Koppeschaar HP, Cohen AF et al. Evidence for brain serotonin-mediated control of carbohydrate consumption in normal weight and obese humans. Int J Obes Relat Metab Disord 1993 September;17(9):513-20.

(189) Pittler MH, Ernst E. Guar gum for body weight reduction: meta-analysis of randomized trials. Am J Med 2001 June 15;110(9):724-30.

(190) Pittler MH, Abbot NC, Harkness EF, Ernst E. Randomized, double-blind trial of chitosan for body weight reduction. Eur J Clin Nutr 1999 May;53(5):379-81.

(191) Pocock SJ, Abdalla M. The hope and the hazards of using compliance data in randomized controlled trials. Stat Med 1998 February 15;17(3):303-17.

(192) Pontiroli AE, Pacchioni M, Piatti PM, Cassisa C, Camisasca R, Pozza G. Benfluorex in obese noninsulin dependent diabetes mellitus patients poorly controlled by insulin: a double blind study versus placebo. J Clin Endocrinol Metab 1996 October;81(10):3727-32.

(193) Rasmussen MH, Andersen T, Breum L, Gotzsche PC, Hilsted J. Cimetidine suspension as adjuvant to energy restricted diet in treating obesity. BMJ 1993 April 24;306(6885):1093-6.

(194) Reaven G, Segal K, Hauptman J, Boldrin M, Lucas C. Effect of orlistat-assisted weight loss in decreasing coronary heart disease risk in patients with syndrome X. Am J Cardiol 2001 April 1;87(7):827-31.

(195) Recasens MA, Barenys M, Sola R, Blanch S, Masana L, Salas-Salvado J. Effect of dexfenfluramine on energy expenditure in obese patients on a very-low-calorie-diet. Int J Obes Relat Metab Disord 1995 March;19(3):162-8.

(196) Redmon JB, Raatz SK, Kwong CA, Swanson JE, Thomas W, Bantle JP. Pharmacologic induction of weight loss to treat type 2 diabetes. Diabetes Care 1999 June;22(6):896-903.

(197) Richelsen B, Pedersen SB, Kristensen K et al. Regulation of lipoprotein lipase and hormone-sensitive lipase activity and gene expression in adipose and muscle tissue by growth hormone treatment during weight loss in obese patients. Metabolism 2000 July;49(7):906-11.

(198) Rigaud D, Trostler N, Rozen R, Vallot T, Apfelbaum M. Gastric distension, hunger and energy intake after balloon implantation in severe obesity. Int J Obes Relat Metab Disord 1995 July;19(7):489-95.

(199) Rigaud D, Ryttig KR, Angel LA, Apfelbaum M. Overweight treated with energy restriction and a dietary fibre supplement: a 6-month randomized, double-blind, placebo-controlled trial. Int J Obes 1990 September;14(9):763-9.

Abstract: Fifty-two (41 females, 11 males) overweight patients, mean body mass index (BMI) = 29.3, were treated for 6 months in a randomized, double-blind, placebo-controlled, parallel group design. The treatment consisted of an energy restricted diet and a dietary fibre supplement amounting to 7 g/day. After treatment the weight reduction in the fibre-treated group, 5.5 +/- 0.7 kg, was significantly higher than that of the placebo group, 3.0 +/- 0.5 kg (P = 0.005). Both groups were normotensive and comparable commencing treatment, 126.5/75.6 +/- 2.0/1.3 mm Hg versus 126.7/78.7 +/- 2.5/1.6 mm Hg. The treatment changed blood pressure non-significantly. Hunger feelings using visual analogue scales (VAS) were significantly reduced from 139.8 +/- 8.2 cm to 118.3 +/- 7.0 cm in the fibre-treated group, whereas a significant increase from 129.5 +/- 6.9 cm to 146.9 +/- 8.8 cm (P less than 0.02) was seen in the placebo group. Side-effects were predominantly gastrointestinal and equally distributed in the two groups. It is concluded that a dietary fibre supplement is of value in the management of overweight, enhancing weight loss and decreasing hunger feelings

(200) Riserus U, Basu S, Jovinge S, Fredrikson GN, Arnlov J, Vessby B. Supplementation with conjugated linoleic acid causes isomer-dependent oxidative stress and elevated C-reactive protein: a potential link to fatty acid-induced insulin resistance. Circulation 2002 October 8;106(15):1925-9.

(201) Rolls BJ, Shide DJ, Thorwart ML, Ulbrecht JS. Sibutramine reduces food intake in non-dieting women with obesity. Obes Res 1998 January;6(1):1-11.

(202) Roongpisuthipong C, Panpakdee O, Boontawee A, Kulapongse S, Tanphaichitr V. Possible thermogenesis with dexfenfluramine. J Med Assoc Thai 1999 February;82(2):150-9.

(203) Rossner S, Sjostrom L, Noack R, Meinders AE, Noseda G. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. European Orlistat Obesity Study Group. Obes Res 2000 January;8(1):49-61.

(204) Rossner S, Andersson IL, Ryttig K. Effects of a dietary fibre supplement to a weight reduction programme on blood pressure. A randomized, double-blind, placebo-controlled study. Acta Med Scand 1988;223(4):353-7.

Abstract: Sixty-two moderately obese (body mass index = 34.8), but normotensive females were treated with a balanced hypocaloric diet providing 1,600 kcal/day and either a 6.5 g dietary fibre supplement or placebo in a randomized, double-blind, parallel group design. During a 12-week treatment programme, weight loss was similar in both groups (4.1 and 4.4 kg, respectively). Initially the blood pressure was 123/76 mmHg in the fibre group compared with 124/74 mmHg in the placebo group (p less than 0.05). In the fibre-treated group a significant fall in diastolic blood pressure by 4 mmHg was found (p less than 0.05). No significant change was seen in the placebo group. It is suggested that dietary fibre may affect blood pressure independently of weight change

(205) Rossner S, von Zweigbergk D, Ohlin A, Ryttig K. Weight reduction with dietary fibre supplements. Results of two double-blind randomized studies. Acta Med Scand 1987;222(1):83-8.

Abstract: We report two studies, in which fibre/placebo tablets were added to a weight reduction regimen in the treatment of moderately obese women. In Study I, 60 females were treated for a two-month period with general dietary advice, providing a mean daily energy intake of 1,400 kcal. In addition, the fibre group received a 5 g dietary fibre supplement. In Study II, 45 females were treated for a three-month period with a similar programme, in which the recommended daily energy intake was 1,600 kcal and the fibre supplement 7 g/day. In both groups weight changes, hunger ratings, blood pressure, defecation pattern and possible side-effects were recorded every second week. Before treatment mean body weight was 95.4 kg (Study I) and 99.3 kg (Study II). Six patients dropped out of Study I, and four out of Study II. In Study I mean weight loss, 7.0 kg, in the fibre group was significantly higher (p less than 0.05) than 6.0 kg in the placebo group. In Study II mean weight loss in the fibre group of 6.2 kg was significantly higher than the 4.1 kg in the placebo group (p less than 0.05). No significant difference in hunger feeling between the groups was found. Systolic blood pressure was reduced in all four groups at the end of the treatment, whereas diastolic blood pressure was reduced only in the fibre group in Study II. The results suggest that dietary fibre is of additive value in the treatment of moderately obese patients. The fibre supplement, however, needs to be comparatively high

(206) Ryttig KR, Tellnes G, Haegh L, Boe E, Fagerthun H. A dietary fibre supplement and weight maintenance after weight reduction: a randomized, double-blind, placebo-controlled long-term trial. Int J Obes 1989;13(2):165-71.

Abstract: Ninety-seven mildly obese females (BMI = 27.4 kg/m2) were in a randomized, double-blind, placebo-controlled trial treated for 52 weeks. The treatment consisted of a hypocaloric diet providing 5000 kJ/day (1200 kcal) and a dietary fibre supplement of 7 g/day for 11 weeks, (part I), followed by a diet providing 6720 kJ/day (1600 kcal) and a dietary fibre supplement of 6 g/day for 16 weeks (part II). Finally placebo was withdrawn and all still adhering subjects were given a dietary fibre supplement of 6 g/day and an ad libitum diet for the rest of the period (part III). Initial body weights were comparable, 76.9 +/- 0.8 kg in the fibre group versus 77.7 +/- 1.3 kg in the placebo group. During part I the weight reduction in the fibre group of 4.9 kg was significantly higher compared to that of 3.3 kg in the placebo group (P = 0.05). Accumulated weight reduction during part II was still significantly higher in the fibre group, 3.8 kg, compared to 2.8 kg in the placebo group (P less than 0.05). Total weight loss in the fibre group after 52 weeks was 6.7 kg. Probability of adherence to the treatment regimen was significantly higher in the fibre group from week 13 and onwards (P less than 0.01). Initial blood pressures were comparable. A significant reduction of systolic blood pressure occurred in both groups. A significant reduction of diastolic blood pressure occurred in the fibre group only, from 85.4 +/- 1.2 mmHg to 81.7 +/- 1.1 mmHg (P less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

(207) Salmela PI, Sotaniemi EA, Viikari J, Solakivi-Jaakkola T, Jarvensivu P. Fenfluramine therapy in non-insulin-dependent diabetic patients: effects on body weight, glucose homeostasis, serum lipoproteins, and antipyrine metabolism. Diabetes Care 1981 September;4(5):535-40.

Abstract: The usefulness of fenfluramine (F), in association with diet therapy, was investigated in 13 obese non-insulin-dependent diabetic patients with poor diabetes control on a previous sulfonylurea regimen (SU). A double-blind crossover comparison of F and placebo (P) consisted of two 7-wk treatment periods. F was administered in stepwise increased and subsequently reduced doses, while the doses of SU were kept unchanged. There was a significant weight loss in F-treated obese subjects as compared with treatment by P. The fasting levels, and particularly the postprandial blood glucose (BG) levels, were significantly lower during F than during P administration. Serum fasting insulin and blood lactate concentrations remained unchanged during the trial. Serum triglycerides and cholesterol decreased during F administration. HDL-cholesterol and apoprotein A-I increased slightly, while apoprotein B decreased during F, but not during P administration. The effect of fenfluramine on hepatic drug metabolism was assessed by using the antipyrine test. F did not cause significant changes in antipyrine metabolism. Fenfluramine therefore seems to be useful as an adjunct to diet and SU therapy in obese non-insulin-dependent diabetic patients

(208) Samsa GP, Kolotkin RL, Williams GR, Nguyen MH, Mendel CM. Effect of moderate weight loss on health-related quality of life: an analysis of combined data from 4 randomized trials of sibutramine vs placebo. Am J Manag Care 2001 September;7(9):875-83.

(209) Sax L. Yohimbine does not affect fat distribution in men. Int J Obes 1991 September;15(9):561-5.

(210) Sayler ME, Goldstein DJ, Roback PJ, Atkinson RL. Evaluating success of weight loss programs, with an application to fluoxetine weight reduction clinical trial data. Int J Obes Relat Metab Disord 1994 November;18(11):742-51.

(211) Scheen AJ. [Info-congress. Prevention of type 2 diabetes in obese patients: first results with orlistat in the XENDOS study]. Rev Med Liege 2002 September;57(9):617-21.

(212) Scheen AJ. [Clinical study of the month. After the storm over central anorectic agents, the "STORM" study of sibutramine]. Rev Med Liege 2001 January;56(1):56-8.

(213) Schteingart DE. Effectiveness of phenylpropanolamine in the management of moderate obesity. Int J Obes Relat Metab Disord 1992 July;16(7):487-93.

Abstract: Phenylpropanolamine (PPA), an over-the-counter drug, is used for weight reduction but its effectiveness is controversial. One hundred and one ambulatory subjects (85 female; 16 male), 21-61 years old, 15-45% overweight but otherwise healthy, were studied. The study was divided into two phases: (i) a double blind (DB), placebo-controlled (P) phase in which all subjects took placebo for two weeks and subsequently took PPA, 75 mg sustained release or placebo for six weeks and (ii) an extended double blind phase in which subjects chose to continue up to 20 weeks. All subjects were instructed on a 5023 kJ (1200 kcal) diet. Both groups lost weight at weeks 4, 6 and 8, but the weight loss was greater for the PPA treated (2.59 kg) than for the placebo treated (1.07 kg) subjects (P = 0.01). Dropout was 29.4% for PPA and 44% for placebo treated subjects. In the 36 subjects who chose to continue in the extended double blind study, the difference persisted (PPA 5.1; placebo 0.4 kg) (P = 0.02). No difference between the groups was observed in blood pressure, pulse rate or subjective side effects. In spite of greater weight loss on PPA, patients did not report a greater anorexic effect. We conclude that PPA enhances weight loss in subjects treated with a hypocaloric diet and is free of untoward side effects

(214) Shapses SA, Von Thun NL, Heymsfield SB et al. Bone turnover and density in obese premenopausal women during moderate weight loss and calcium supplementation. J Bone Miner Res 2001 July;16(7):1329-36.

(215) Silverstone T. Clinical use of appetite suppressants. Drug Alcohol Depend 1986 June;17(2-3):151-67.

(216) Sjostrom L, Rissanen A, Andersen T et al. [Randomized placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients]. Ter Arkh 2000;72(8):50-4.

(217) Sjostrom L, Rissanen A, Andersen T et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group. Lancet 1998 July 18;352(9123):167-72.

(218) Slama G, Selmi A, Hautecouverture M, Tchobroutsky G. Double blind clinical trial of mazindol on weight loss blood glucose, plasma insulin and serum lipids in overweight diabetic patients. Diabete Metab 1978 September;4(3):193-9.

Abstract: Mazindol, a drug with tricyclic structure unrelated to amphetamine and other anorectic drugs, has been used as an anorectic agent in a double blind clinical trial at a dose of 2 mg/day for 12 week (mazindol v. s. placebo), associated with a 1000 calorie diet on 46 obese diabetic patients. Thirty seven patients completed the trial with no significant difference between the two groups in the drop-out population; mazindol was well tolerated. In the mazindol-treated group the mean weight loss was 13.5 kg (22.3%) which was significantly greater (p less than 0.001) than in the placebo treated group where the mean weight loss was 4.2 kg (9.8%). Comparing the two groups after the 12 week trial, decrease in fasting blood glucose, serum insulin and triglycerides was not significant. In the mazindol-treated group a significant decrease of serum cholesterol, triglycerides and of the mean area under the curve of insulinemia during the OGTT has been observed. In the placebo treated group only serum triglycerides decreased significantly. The variations of plasma insulin and serum cholesterol were found to be correlated to the magnitude of weight loss. In conclusion mazindol is an effective drug for weight loss on the whole well tolerated but without specific properties on metabolism

(219) Smith IG, Goulder MA. Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity. J Fam Pract 2001 June;50(6):505-12.

(220) Solum TT, Ryttig KR, Solum E, Larsen S. The influence of a high-fibre diet on body weight, serum lipids and blood pressure in slightly overweight persons. A randomized, double-blind, placebo-controlled investigation with diet and fibre tablets (DumoVital). Int J Obes 1987;11 Suppl 1:67-71.

Abstract: Sixty slightly overweight women were treated with a weight-reducing diet for 12 weeks in a randomized, double-blind, placebo-controlled study. In addition to the diet 30 women received dietary fibre tablets, whereas the remaining 30 women received identical-looking placebo tablets. During the trial both groups experienced a significant reduction in body weight (P less than 0.01). The mean weight loss 8.5 kg (7.5-9.5 kg) in the fibre group was significantly higher than that of the placebo group 6.7 kg (4.8-8.0 kg) (P less than 0.01). Both serum triglyceride and serum cholesterol concentrations were significantly lowered (P less than or equal to 0.02) after treatment in both groups. No significant differences were detected between the groups. Both systolic and diastolic blood pressure were significantly reduced (P less than 0.01) in the fibre group. No significant reduction in blood pressure was found in the placebo group. Side-effects, which were gastrointestinal in nature, were of low frequency. We conclude that supplementation with dietary fibre of the form used in this study is useful in the treatment of overweight women

(221) Spring B, Wurtman J, Wurtman R et al. Efficacies of dexfenfluramine and fluoxetine in preventing weight gain after smoking cessation. Am J Clin Nutr 1995 December;62(6):1181-7.

Abstract: We tested whether 14 wk of dexfenfluramine (30 mg) or fluoxetine (40 mg) treatment would prevent weight gain after subjects quit smoking. Normal-weight women (n = 144) were randomly assigned to drug or placebo on a double-blind basis for 2 wk before quitting smoking and 12 wk thereafter. The fluoxetine group had more dropouts (28/49, 57.1%) than the dexfenfluramine group (17/47, 36.2%), with an intermediate number of dropouts from the placebo group (21/48, 43.8%). All groups gained weight during treatment, but their amount and pattern of weight gain differed. In the first month after quitting smoking, the placebo group gained more weight than either the dexfenfluramine or fluoxetine group (P < 0.05). By 2 mo postcessation, dexfenfluramine still suppressed weight gain in comparison with placebo (P < 0.05); weight gain with fluoxetine was not differentiable from either dexfenfluramine or placebo. By 3 mo postcessation, the dexfenfluramine group had gained 1.0 +/- 0.7 kg, significantly less than either the placebo (3.5 +/- 0.7 kg) or fluoxetine (2.7 +/- 0.5 kg) groups. Three months after drug discontinuation, formerly medicated, but not placebo patients, showed additional weight gain, eliminating differences between groups. Results indicate that weight gain, an adverse accompaniment of smoking cessation, can be minimized to some degree by serotoninergic drugs, although only for the duration of drug treatment

(222) Sramek JJ, Leibowitz MT, Weinstein SP et al. Efficacy and safety of sibutramine for weight loss in obese patients with hypertension well controlled by beta-adrenergic blocking agents: a placebo-controlled, double-blind, randomised trial. J Hum Hypertens 2002 January;16(1):13-9.

(223) Stahl KA, Imperiale TF. An overview of the efficacy and safety of fenfluramine and mazindol in the treatment of obesity. Arch Fam Med 1993 October;2(10):1033-8.

(224) Starling RD, Liu X, Sullivan DH. Influence of sibutramine on energy expenditure in African American women. Obes Res 2001 April;9(4):251-6.

Abstract: OBJECTIVE: African American women have a high prevalence of obesity, which partially may be explained by their lower rates of resting energy expenditure (REE). The aim of this study was to examine the influence of acute sibutramine administration on REE and post-exercise energy expenditure in African American women. RESEARCH METHODS AND PROCEDURES: A total of 15 premenopausal, African American women (age, 29 +/- 5 years; body fat, 38 +/- 7%) completed a randomized, double-blind cross-over design with a 30-mg ingestion of sibutramine or a placebo. Each trial was completed a month apart in the follicular phase and included a 30-minute measurement of REE 2.5 hours after sibutramine or placebo administration. This was followed by 40 minutes of cycling at approximately 70% of peak aerobic capacity and a subsequent 2-hour measurement of post-cycling energy expenditure. RESULTS: There was no difference (p > 0.05) in REE (23.70 +/- 2.81 vs. 23.69 +/- 2.95 kcal/30 min), exercise oxygen consumption (1.22 +/- 0.15 vs. 1.25 +/- 0.15 liter/min), and post-cycling energy expenditure (104.2 +/- 12.7 vs. 104.9 +/- 11.4 kcal/120 min) between the sibutramine and placebo trials, respectively. Cycling heart rate was significantly higher (p = 0.01) during the sibutramine (158 +/- 14 beats/min) vs. placebo (150 +/- 12 beats/min) trials. DISCUSSION: These data demonstrate that acute sibutramine ingestion does not increase REE or post-exercise energy expenditures but does increase exercising heart rate in overweight African American women. Sibutramine may, therefore, impact weight loss through energy intake and not energy expenditure mechanisms

(225) Stevenson JH, Trojian T, Jackson EA. Does long-term use of sibutramine (Meridia) result in continued weight loss in short-term responders? J Fam Pract 2001 December;50(12):1084.

(226) Stewart GO, Stein GR, Davis TM, Findlater P. Dexfenfluramine in type II diabetes: effect on weight and diabetes control. Med J Aust 1993 February 1;158(3):167-9.

Abstract: OBJECTIVE: To assess the effect of dexfenfluramine on weight loss, diabetic control and blood lipids in type II diabetics over a three-month period. DESIGN, SETTING AND PATIENTS: Forty overweight patients in the Diabetic Clinic, Fremantle Hospital, were studied in a double-blind, placebo-controlled trial with a run-in period of one month followed by three months on either dexfenfluramine or placebo. MAIN OUTCOME MEASURES: Changes in body weight, and fasting plasma glucose, glycosylated haemoglobin, plasma cholesterol and triglyceride levels. MAIN RESULTS: The median change in weight was -3.8 kg in the treatment group (Df) and +0.3 kg in the placebo group (PI) (P = 0.006). The median changes in fasting plasma glucose levels were -1.0 mmol/L (Df) and +0.6 mmol/L (PI) P = 0.010). The median changes in glycosylated haemoglobin levels were -1.4% (Df) and +0.2% (PI) (P = 0.002). The median changes in triglyceride levels were -0.3 mmol/L (Df) and +0.2 mmol/L (PI) (P = 0.017). Cholesterol level did not change significantly. CONCLUSION: Dexfenfluramine is effective in achieving weight loss and also improved diabetic control in obese type II diabetics over a three-month period

(227) Stinson JC, Murphy CM, Andrews JF, Tomkin GH. An assessment of the thermogenic effects of fluoxetine in obese subjects. Int J Obes Relat Metab Disord 1992 May;16(5):391-5.

Abstract: Fluoxetine is an antidepressant drug with weight reducing properties. To assess whether fluoxetine has an ability to promote diet induced thermogenesis (DIT), 30 obese subjects (BMI 30-45 kg/m2) underwent a double blind, randomized, cross-over trial of 60 mg fluoxetine versus placebo. A two week single blind, run-in period on placebo was incorporated into the study to allow for placebo responders. The first stage of the study lasted for 14 days followed by a six week cross-over wash-out phase and concluded with the second 14 day stage of the study. An estimate of resting metabolic rate (RMR) was measured by continuous indirect calorimetry using the ventilated hood technique. Metabolic measurements were performed on six occasions, immediately before the first tablet was taken in the first stage, 24 hours after the first tablet was consumed and on the last day of the first stage; these three recordings were repeated on the second stage of the study. On each occasion a control reading of RMR was taken for 30 minutes then DIT was measured for 90 minutes following a lemon and glucose drink (1 g/kg body weight). Whilst a significant weight reduction (1.16 kg, P less than 0.05) occurred in the active stage, no such effect was achieved in the placebo phase. No differences were found between the two stages with regard to RMR, total DIT, peak DIT and time taken to reach peak DIT. We conclude that fluoxetine does not stimulate metabolism and that the weight reduction after 14 days therapy is due to other mechanisms

(228) Sullivan AC, Comai K. Pharmacological treatment of obesity. Int J Obes 1978;2(2):167-89.

Abstract: Obesity results when the ingestion of energy exceeds its utilization, leading to an excessive expansion of the adipose tissue mass. Current pharmacological therapy for the obese patient focuses primarily on reducing energy intake. Anorectic agents reduce food consumption by modifying central systems in the brain which are involved in appetite regulation. These agents are reviewed in terms of mechanism of action, and clinical safety and efficacy in suppressing appetite and promoting weight loss. Newer anorectic agents which are being evaluated currently in clinical and animal studies are described. Clinical assessments of therapeutic regimens utilizing the thyroid hormones and human chorionic gonadotropin are evaluated. Finally, an overview of novel pharmacological approaches to the treatment of obesity is presented

(229) Szkudlarek J, Elsborg L. Treatment of severe obesity with a highly selective serotonin re-uptake inhibitor as a supplement to a low calorie diet. Int J Obes Relat Metab Disord 1993 December;17(12):681-3.

(230) Thompson JL, Butterfield GE, Gylfadottir UK et al. Effects of human growth hormone, insulin-like growth factor I, and diet and exercise on body composition of obese postmenopausal women. J Clin Endocrinol Metab 1998 May;83(5):1477-84.

(231) Toornvliet AC, Pijl H, Frolich M, Westendorp RG, Meinders AE. Insulin and leptin concentrations in obese humans during long-term weight loss. Neth J Med 1997 September;51(3):96-102.

(232) Toubro S, Astrup A, Breum L, Quaade F. The acute and chronic effects of ephedrine/caffeine mixtures on energy expenditure and glucose metabolism in humans. Int J Obes Relat Metab Disord 1993 December;17 Suppl 3:S73-S77.

(233) Toubro S, Astrup AV, Breum L, Quaade F. Safety and efficacy of long-term treatment with ephedrine, caffeine and an ephedrine/caffeine mixture. Int J Obes Relat Metab Disord 1993 February;17 Suppl 1:S69-S72.

(234) Toubro S, Astrup A, Breum L, Quaade F. The acute and chronic effects of ephedrine/caffeine mixtures on energy expenditure and glucose metabolism in humans. Int J Obes Relat Metab Disord 1993 December;17 Suppl 3:S73-S77.

(235) Toubro S, Astrup AV, Breum L, Quaade F. Safety and efficacy of long-term treatment with ephedrine, caffeine and an ephedrine/caffeine mixture. Int J Obes Relat Metab Disord 1993 February;17 Suppl 1:S69-S72.

(236) Trent LK, Thieding-Cancel D. Effects of chromium picolinate on body composition. J Sports Med Phys Fitness 1995 December;35(4):273-80.

(237) Van Gaal LF, Wauters MA, Peiffer FW, De Leeuw IH. Sibutramine and fat distribution: is there a role for pharmacotherapy in abdominal/visceral fat reduction? Int J Obes Relat Metab Disord 1998 August;22 Suppl 1:S38-S40.

(238) Van Gaal LF, Broom JI, Enzi G, Toplak H. Efficacy and tolerability of orlistat in the treatment of obesity: a 6-month dose-ranging study. Orlistat Dose-Ranging Study Group. Eur J Clin Pharmacol 1998 April;54(2):125-32.

(239) Van Gaal LF, Vansant GA, Steijaert MC, De Leeuw IH. Effects of dexfenfluramine on resting metabolic rate and thermogenesis in premenopausal obese women during therapeutic weight reduction. Metabolism 1995 February;44(2 Suppl 2):42-5.

(240) Vestergaard P, Borglum J, Heickendorff L, Mosekilde L, Richelsen B. Artifact in bone mineral measurements during a very low calorie diet: short-term effects of growth hormone. J Clin Densitom 2000;3(1):63-71.

(241) Villani RG, Gannon J, Self M, Rich PA. L-Carnitine supplementation combined with aerobic training does not promote weight loss in moderately obese women. Int J Sport Nutr Exerc Metab 2000 June;10(2):199-207.

(242) Visser M, Seidell JC, Koppeschaar HP, Smits P. The effect of fluoxetine on body weight, body composition and visceral fat accumulation. Int J Obes Relat Metab Disord 1993 May;17(5):247-53.

(243) Wadden TA, Berkowitz RI, Womble LG, Sarwer DB, Arnold ME, Steinberg CM. Effects of sibutramine plus orlistat in obese women following 1 year of treatment by sibutramine alone: a placebo-controlled trial. Obes Res 2000 September;8(6):431-7.

(244) Wales JK. The effect of fenfluramine on obese, maturity-onset diabetic patients. Acta Endocrinol (Copenh) 1979 April;90(4):616-23.

Abstract: In 38 obese maturity-onset diabetic patients the effect of fenfluramine therapy on carbohydrate tolerance was compared to placebo therapy in a double blind trial. Fenfluramine therapy did not affect weight loss, or fasting glucose levels but produced a slight but significant improvement in glucose tolerance. This improvement was not correlated with any change in body weight or insulin secretion

(245) Walsh DE, Yaghoubian V, Behforooz A. Effect of glucomannan on obese patients: a clinical study. Int J Obes 1984;8(4):289-93.

Abstract: